Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)  
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Mouse Metabolic Phenotyping Centers Consortium (U24)

Announcement Type
This is a reissue of RFA DK-05-008.

Request For Applications (RFA) Number: RFA-DK-10-006

Catalog of Federal Domestic Assistance Number(s)
93.847, 93.837

Key Dates  
Release Date: August 9, 2010
Letters of Intent Receipt Date: October 21, 2010  
Application Receipt Date: November 18, 2010
Peer Review Date(s): February/March 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: June 01, 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable.
Expiration Date: November 19, 2010

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary  

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Dispute Resolution Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

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 identifying and validating new mouse models of human disease.

The Mouse Metabolic Phenotyping Centers program (MMPC) was established in 2001 (RFA DK-00-014) and renewed in 2006 (RFA DK-05-008). 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. The focus of the MMPC consortium is on assays performed with living animals, and on technologies that are valuable for understanding metabolism and physiology that are not widely available. Researchers ship mice to an MMPC where they are phenotyped on a fee-for-service basis. The user group for these centers are NIH grantees and others, academic and non-academic researchers, both 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, and a pilot research project funding program. These resources coordinate efforts within the consortium and provide a unique phenotyping data resource for the research community. The MMPC Coordinating and Bioinformatics Unit (CBU) houses the MMPC database, and is responsible for overseeing collaborative activities of the consortium. The MMPC CBU will be funded through a separate initiative (RFA-DK-10-007).

Each application may request funds for one Mouse Metabolic Phenotyping Center (MMPC).

Research Topics

Phenotyping Centers may provide diagnostic services in one or many disease areas. Examples of disease areas that can be proposed for services include, but are not limited to:

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 Evaluation Committee (EEC). Individual MMPC phenotyping centers will have a Center Director (PI) and an Associate Director, who would become the Center Director if the 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, and one or more Phenotyping Cores. 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.

Consortium Activities and Responsibilities

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

Executive Steering Committee

The Principal Investigator/Director 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 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 chosen from among the MMPC Center Directors and may rotate annually. The role of the NIDDK Project Scientist is described under COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF THE AWARD, Section VI 2.A.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 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 the MMPC pilot and feasibility program.

External Evaluation Committee (EEC)

The Principal Investigator/Director of the MMPC must indicate a commitment to be responsive to recommendations provided by an independent External Evaluation Committee (EEC). The MMPC EEC will meet annually to review interim progress and will provide an annual report and recommendations to NIDDK and 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 EEC will be nominated by the MMPC Executive Steering Committee, selected and invited by the NIH. A chairman will be chosen from among the EEC 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 EEC and the EEC chair hold one vote each. The Executive Steering Committee will discuss implementation of EEC recommendations, and provide a timeline and action plan for making changes in a timely fashion. The action plan will be reported to the EEC.

Description of a Phenotyping Center (MMPC)

Phenotyping and Analysis Cores

The most important aspect to be considered in an MMPC application are the proposed Phenotyping and Analysis Cores. 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 should be able to 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 may choose to provide either standard or customized 'exams' for various models, and should propose a method to advise users in order to determine the appropriate series of tests.

Applicants must carefully justify the needs being uniquely addressed, and describe the methodologies,  technologies, statistical tools, limitations of the approaches, and projected costs of the approaches. Applicants must indicate the number of animals that could be studied each year for each test, and phenotyping must be applicable to the major mouse strains used for research. Centers will be required to establish 'normal' parameters for each test on the appropriate wild type background strains. 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.

Each funded center will have unique strengths, either because of the technologies available to it, or because of specialized local expertise. 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:

Research and Development

Each MMPC will be expected to foster the development and implementation of new technologies and tests for phenotyping mouse models of disease. It is expected that MMPC Research and Development activities will provide new protocols 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 plan data mining projects for the MMPC database as it is populated with publicly available test data from many animal models. 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.

Animal Care Core

The Animal Care Core will receive, house, feed, monitor and maintain the health of submitted mice for the duration required for the phenotyping exam. MMPC Animal Care Guidelines are posed at the MMPC website (http://www.mmpc.org/), and applications should contain a willingness to follow these guidelines, and provide details for any necessary deviations. Proposals 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. In most cases animals will be shipped to MMPCs, and it is not anticipated that animals will be returned to the originating institution.

MMPC Steering Committee

The Administrative Core will establish a 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. The Center Steering Committee will monitor workflow and customer service; assess market trends and emerging opportunities; oversee research and development and pilot and feasibility programs, and evaluate their impact on center vitality; approve new tests; determine when test fees should be waived or when collaborative arrangements are justified; and participate in other ways as necessary.

Administrative Core

A well-organized administrative core is essential to ensure the efficiency and success of the center. In consultation with the Coordinating and Bioinformatics Unit, the Administrative Core of each Phenotyping Center must maintain Center budgetary and workflow records; oversee the importation and workflow assignments for strains submitted for services; establish, standardize, document and distribute phenotyping protocols; 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 50% or greater time commitment. The Administrative Core must provide the following:

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. Additional overhead costs are allowed, but should not make fees so high as to constitute an undue burden on the user. Centers may have exemption programs where permission to waive fees is requested from the internal MMPC Steering Committee, and this should be addressed in the application. These might cover new investigators, small pilot studies and P&F projects. Center personnel are expected to advise applicants for services regarding the best set of tests, and there should be no charge for planning and advice. Program income should be used to improve and expand the Centers. Appropriate uses would be for new equipment, new tests, additional lab staff, training, etc. Applications should have a detailed plan for fee structure, cost recovery, and how program income will be used. 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.

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 data subsequently provided by the MMPC belongs to them, and does not obligate them to a collaboration, nor are they expected to share authorship with Center personnel when these 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 Mouse/Tissue Transfer Agreement http://www.mmpc.org/MTA.pdf that indicates that 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.

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. MMPCs must agree to accept, house and care for mice shipped from outside their home institutions, and to conduct agreed upon tests. Applicants must 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. 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. MMPCs will each maintain a website. MMPC directors will participate in the Executive Steering Committee. All data generated on submitted test strains belongs to the originating investigator and institution. All data from test and control mice will be posted in the MMPC database, which will be accessed via http://www.mmpc.org/. Data from test mice will be made available to the public after publication or at an appropriate time after data was generated (typically 2 years). A Mouse/Tissue Transfer Agreement to this effect must be signed for each set of mice to be studied (http://www.mmpc.org/MTA.pdf).

Description of the MMPC Coordinating and Bioinformatics Unit (CBU)

The MMPC Coordinating and Bioinformatics Unit (CBU) will be shared with the NIDDK Models of Diabetic Complications Consortium and will be competed through a separate RFA (RFA-DK-10-007). 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 Opportunity Pool, 4) updating and maintaining the MMPC internet and intranet websites, 5) providing logistics and other support for consortial meetings, and 5) promoting the consortium via advertising and through facilitating collaborative efforts.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U24 award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". Plans for renewal of this opportunity beyond this award period are currently indefinite, and will depend on institute needs and availability of funds.

2. Funds Available  

The NIDDK and NHLBI intend to commit approximately $4,310,000 in FY 2011 to fund four to six new or continuing MMPC awards in response to this FOA. An applicant may request a project period of up to five years and a budget of up to $600,000 direct costs per year for each of five years.

The estimated amount of funds available for support of four to six projects awarded as a result of this announcement is $4,310,000 for fiscal year 2011. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals.  Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: October 21, 2010
Application Receipt Date: November 18, 2010
Peer Review Date: February/March 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: June 1, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabets and Digestive and Kidney Diseases
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@nih.gov

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabets and Digestive and Kidney Diseases
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@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

The following section supplements the instructions found in Form PHS 398 for preparing multi-component grant applications.  Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-component applications consisting of core facilities interrelated by a common theme. Incomplete and/or non-responsive applications will not be reviewed.

The order of presentation should be as follows:

The supplemental instructions below are divided as follows:

A. General Instructions

B. Specific Instructions for Cores

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-component grant application should be assembled and paginated as one complete document.

A1. Form Page 1 – Face Page

Items 1-14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page.

A2. Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL application addressing the major common themes and capabilities addressed by the center. Do not exceed the space provided.

A3. Form Page 3 – Table of Contents

Bearing in mind that the application will be scientifically reviewed with regard to the overall objectives of the center and individual cores, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component core. A page reference should be included for the budget for each core. Further, each core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the “Table of Contents”.

A4. Composite Budget

Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. Justification for budget elements should not be presented here but in the individual budgets of the cores.

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

COMPONENT

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Core A. Admin

50,000

50,000

50,000

50,000

50,000

250,000

Core B. Animal Care

50,000

50,000

50,000

50,000

50,000

250,000

Core C. Physiology

50,000

50,000

50,000

50,000

50,000

250,000

Core D. Metabolism

50,000

50,000

50,000

50,000

50,000

250,000

TOTAL Direct Costs

200,000

200,000

200,000

200,000

200,000

1,000,000


A5. Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each core (see below).

A6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the applications with the PD/PI(s) first, followed by those of other key personnel in alphabetical order.

A7. Resources Format Page

Do not complete. Essential information is to be presented in the individual core sections of the application.

A8. Center Overview (Objectives and Strategic Plan; up to 12 pages)

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.

If the application is a renewal, this section should also highlight past performance and the major accomplishments from the prior funding period as described in the PHS 398 Instructions. Data reflecting center activities should be provided in the tabular form and format outlined below. Numbers of users and services should be provided as totals, and also broken down according to users and services provided to local customers as versus customers from outside the parent institution. Numbers of publications citing the center that contain center personnel as co-authors should be clearly indicated. 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 Plan within each core.

SAMPLE: Center Activities, Productivity and Program Income in the Prior Project Period

MMPC Functions

Project Year 1

Project Year 2

Project Year 3

Project Year 4

Project Year 5

Project All Years

Users Core A (#local/#outside)

50 (10/40)

70 (10/60)

90   (20/70)

110 (30/80)

130 (30/100)

450 (100/350)

Services Core A (#local/#outside)

100 (20/80)

140 (20/120)

180 (40/140)

220 (60/160)

260 (60/200)

900 (200/700)

Users Core B (#local/#outside)

50 (10/40)

70 (10/60)

90   (20/70)

110 (30/80)

130 (30/100)

450 (100/350)

Services Core B (#local/#outside)

100 (20/80)

140 (20/120)

180 (40/140)

220 (60/160)

260 (60/200)

900 (200/700)

Users Core C (#local/#outside)

50 (10/40)

70 (10/60)

90   (20/70)

110 (30/80)

130 (30/100)

450 (100/350)

Services Core C (#local/#outside)

100 (20/80)

140 (20/120)

180 (40/140)

220 (60/160)

260 (60/200)

900 (200/700)

Publications citing MMPC: with center co-authorship

10

20

30

40

50

150

Total Publications citing MMPC: no center co-authorship

20

40

60

80

100

300

Program Income

$50,000

$100,000

$150,000

$200,000

$250,000

$750,000


A9. Leadership Plan for Multiple PDs/PIs (required, if applicable)

For applications designating multiple PDs/PIs, a section entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and its relationship to the center and core structure should be described, and should include communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the program should be delineated for the PDs/PIs and other collaborators including responsibilities for animal studies as appropriate.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

A10. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

A11. Appendix Materials

For each core in the multi-component application, 3 non-publically available plus other approved material are allowed. For additional information, see Section IV.6 “Other Submission Requirements and Information”.

B. Specific Instructions for Cores

Except for the requirements below, follow the PHS 398 Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc13079700 in preparing each proposed core.

Each Core must include:

B1. Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-component application. Instead, use the PHS 398 continuation page to create a “Cover Page” containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:

Core Letter and Core Title: (e.g., A. Administrative Core)

Name of Core Leader: (e.g., Smith, Robert A.)

Vertebrate Animals (Yes or No)   If Yes,

IACUC Approval Date (e.g., 4/15/2010, or Pending), and Animal Welfare Assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2010)

To: (mmddyy, e.g., 6/30/2015)

Costs Requested for Initial Budget Period

Direct Costs (e.g., $50,000)

Total Costs (e.g., $70,000)

Costs for the Entire Budget Period

Direct Costs (e.g., $250,000)

Total Costs (e.g., $350,000)

Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)

B2. Form Page 2

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of center and MMPC program objectives.

List the performance sites where the core activities will be conducted.

Under “Key Personnel”, list the Core Leader, followed by other key core personnel, and then other significant contributors.

B3. Form Page 3

Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.

B4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and budget justification for the core using Form Pages 4 and 5 of the PHS 398.

B5. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

B6. Resources Format Page

Provide information on resources available for the core.

B7. Core Research Plan

Note: Items 2-5 cannot exceed 12 pages for each core.

Item 2 – Specific Aims: List in priority order the broad, long-range objectives of the proposed core. In addition, state the unmet needs being addressed by the core, its interaction with other cores in the application, and its relationship (if any) to similar cores available in the institution or elsewhere in the US.

Item 3 – Background and Significance: Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives of the center and the national MMPC program. Explain the rationale for selection of core services, and describe the general methods and approaches that will be used to accomplish the specific aims.

Item 4 – Preliminary Studies/Progress Report: Describe the proposed core’s services and expertise, and how the core activities as designed will address a compelling and unmet need for the research community. 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 users and services provided to local customers as 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: Core Activities, Productivity and Program Income in the Prior Project Period

CORE A

Project Year 1

Project Year 2

Project Year 3

Project Year 4

Project Year 5

Project All Years

Users Service A (#local/#outside)

5    (1/4)

7       (1/6)

9         (2/7)

11       (3/8)

13   (3/10)

45 (10/35)

Services/assays A (#local/#outside)

10  (2/8)

14   (2/12)

18     (4/14)

22     (6/16)

26    (6/20)

90 (20/70)

Users Service B (#local/#outside)

5    (1/4)

7       (1/6)

9         (2/7)

11       (3/8)

13   (3/10)

45 (10/35)

Services/assays B (#local/#outside)

10  (2/8)

14   (2/12)

18     (4/14)

22     (6/16)

26    (6/20)

90 (20/70)

Users Service C (#local/#outside)

5    (1/4)

7       (1/6)

9         (2/7)

11       (3/8)

13   (3/10)

45 (10/35)

Services/assays C (#local/#outside)

10     (2/8)

14   (2/12)

18     (4/14)

22     (6/16)

26   (6/20)

90 (20/70)

Publications citing Core A with center co-authorship

1

2

3

4

5

15

Publications citing Core A no center co-authorship

2

4

6

8

10

30

Program Income

$5000

$10,000

$15,000

$20,000

$25,000

$75,000


Item 5 – Research Design and Methods: State the roles and responsibilities of the core leader, roles of key personnel, and functions of the proposed core.

B8. Appendix

All appendix materials should be collated as one body of material and submitted on CD as described below in Section IV.6.  

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications.  Resubmission applications are not permitted in response to this FOA.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

The following evaluation criteria will be used to assess the progress of renewal MMPC  applications, and were developed by the MMPC Executive Steering and External Evaluation Committees:

These criteria may be weighted differently for different types of projects. For instance, some tests have high demand and are relatively high throughput, and generate a considerable number of publications that do not have MMPC staff as authors. Other tests may be very novel but potentially powerful, may have a small but important clientele, may be difficult and low throughput, but provide important results and deliver rare technology to a wider circle of researchers than would otherwise have access to it. Such tests may require substantial time and input, and in these cases it may be more appropriate for MMPC staff to be represented as coauthors on resultant publications.

Revision Applications.  Revisions are not allowed for this FOA.

Additional Review Considerations

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

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

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator/Director of the Mouse Metabolic Phenotyping Center will have primary responsibility for all activities, including the p lanning , organizing and administering the phenotyping, administration and animal cores, a Research and Development program, and an internal Steering Committee. He/She will participate as a voting member of the MMPC Executive Steering Committee with NIH staff, the MMPC CBU PI, and other MMPC Center Directors. He/She will be responsible for evaluating applications for phenotyping services, and will ensure that services are completed, and that data is placed in the MMPC database in a timely and satisfactory manner. The PI will ensure that Center personnel follow the MMPC guidelines and policies found on http://www.mmpc.org.

Awardees will retain custody of and have primary rights to the data and software developed under these awards that are not assigned to the external investigators that use the MMPC according to the Mouse/Tissue Transfer Agreement found at http://www.mmpc.org/MTA.pdf, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist [or “Project Coordinator,” or “Project Collaborator,” or “Intramural Scientist”] will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. An NIDDK Project Scientist will have substantial involvement in the project above and beyond normal stewardship and monitoring of the award, as described below. 

The NIDDK 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.

For multi-center studies, the NIDDK project scientist will participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be 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:

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 monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.

The NIDDK Program Official will be responsible for appointment of a Data and Safety Monitoring Board (DSMB) as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the DSMB. 

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.

2.A.3. Collaborative Responsibilities

Consortium Activities and Responsibilities

The Principal Investigator (PI) of the MMPC must agree to be an active participant in consortium-wide activities as deemed necessary by appropriate oversight committees.

Executive Steering Committee

The Principal Investigator/Director of the MMPC must agree to participate in the Executive Steering Committee (ESC) 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 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 of the ESC 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 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.

External Evaluation Committee (EEC)

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

Members of the EEC will be nominated by the Executive Steering Committee, selected and invited by the NIH staff.  A chairman will be chosen from among the EEC membership, who will be an 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 EEC and the EEC chair hold one vote each. The Executive Steering Committee will discuss implementation of EEC recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report an action plan back to the EEC.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting
 

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Kristin Abraham, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 795
Bethesda, MD 20892-5460
Telephone: (301) 451-8048
Email: ka136s@nih.gov

Narasimhan Danthi, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 8218
Bethesda, MD 20892-7940
Telephone: (301) 435-0513
Email: ndanthi@mail.nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabets and Digestive and Kidney Diseases
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@nih.gov

3. Financial or Grants Management Contacts:

Christina Coriz
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 709A
Bethesda, MD 20892-5456
Telephone: (301) 594-8848
Email: corizc@niddk.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.