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://www.niddk.nih.gov)

Title: Coordinating and Bioinformatics Unit for the Mouse Metabolic Phenotyping Centers and Animal Models of Diabetic Complications Consortium

Announcement Type
New

Update: The following update relating to this announcement has been issued:

• August 9, 2010 - This RFA has been reissued as (RFA-DK-10-007).

Request For Applications (RFA) Number: RFA-DK-05-012

Catalog of Federal Domestic Assistance Number(s)
93.847, 93.849

Key Dates
Release Date: June 8, 2005
Letters of Intent Receipt Date(s): October 18, 2005
Application Receipt Dates(s): November 16, 2005
Peer Review Date(s): February March 2006
Council Review Date(s): May 31-June 01, 2006
Earliest Anticipated Start Date: September 01, 2006
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: November 17, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• This Request for Applications (RFA) solicits applications for a Coordinating and Bioinformatics Unit (CBU) to be shared by the national Mouse Metabolic Phenotyping Centers (MMPC) and Animal Models of Diabetic Complications Consortium (AMDCC). The CBU will develop, house and maintain the websites and databases, will carry out administrative tasks and organize both separate and joint meetings for these consortia, and will distribute funds and provide financial management for the MMPC Pilot and Feasibility program.
• The MMPC (RFA-DK-05-008) conducts detailed metabolic phenotyping of genetically altered mice and other mouse models that are useful for understanding diabetes and its complications, obesity, and related metabolic diseases or conditions. Mice can be shipped to these facilities to undergo on a fee-for-service basis a range of standardized procedures to characterize metabolism, body composition, feeding behavior, activity, tissue pathology, organ function, and other physiologic, anatomic or pathological alterations. Information about the current MMPCs, including a catalog of services, guidelines and policies, can be found at http://www.mmpc.org.
• The AMDCC (RFA-DK-05-011) generates and phenotypes new models of diabetes complications in mice and in selected other species. Information about the current AMDCC can be found at http://www.amdcc.org/.
• The NIDDK anticipates awarding one Coordinating and Bioinformatics Unit (CBU) in response to this RFA.
• The total amount to be awarded is up to $1.0 million for the first year and $750,000 for each of 4 additional years, for a total of 5 years. This includes $300,000 direct costs in each year to be distributed as MMPC Pilot and Feasibility research awards.
• This RFA will use the U24 Resource Related Research Projects Cooperative Agreement mechanism. The CBU will serve the coordination and bioinformatics needs of the AMDCC and MMPC, with substantial involvement from NIH staff.
• For-profit and non-profit organizations are eligible, including public or private institutions, units of state and local governments, eligible agencies of the federal government, and domestic institutions/organizations.
• Any individual with the skills, knowledge, and resources necessary to execute the functions proposed for the MMPC/AMDCC Coordinating and Bioinformatics Unit is invited to work with their institution 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 programs.
• Investigating institutions may submit one application to this RFA.
• Applications must be prepared using the PHS 398 research grant application and forms (rev. 09/2004; http://grants.nih.gov/grants/funding/phs398/phs398.html).
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives
2. Research Support Activities

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
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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. Arbitration 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

1. Research Objectives

Background

The NIDDK supports two independent basic-science consortia that are designed to generate or facilitate phenotyping of animal models of disease. Both of these consortia (the Mouse Metabolic Phenotyping Centers and the Animal Models of Diabetic Complications Consortium) acquire data pertinent to animal models of NIDDK-relevant human diseases. The purpose of this RFA is to solicit applications for a Coordinating and Bioinformatics Unit that will jointly serve the administrative and bioinformatics needs of these two projects.

The mission of the Mouse Metabolic Phenotyping Centers (MMPC; http://www.mmpc.org) 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 MMPC is currently a consortium of four Centers founded in 2001 through RFA-DK-00-014 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-00-014.html). It will be renewed through grants awarded under a companion RFA-DK-05-008. In addition to the cooperative research grants supporting fee-for-service phenotyping activities, the MMPC supports an administrative infrastructure and collaborative research database. The resources created through the MMPC awards and their associated administrative structures and database were intended to substantially accelerate efforts toward identification and validation of mouse models for diseases within the NIDDK mission.

The goal of the Animal Models of Diabetic Complications Consortium (AMDCC; http://www.amdcc.org) is to develop new and innovative animal models of diabetic complications to support translational research for these conditions. The current AMDCC is a consortium of 9 projects that originated in 2001 through RFA DK-01-009 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-009.html). It will be renewed through grants awarded under a companion RFA-DK-05-011. In addition to consortium projects generating and validating new models of diabetic complications, the AMDCC is supported by a Coordinating and Bioinformatics unit that is responsible for establishing and maintaining the AMDCC website and database, and for coordinating consortium activities.

In 2006, the NIDDK intends to consolidate ongoing coordination and bioinformatics activities within the MMPC and AMDCC into a single MMPC/AMDCC Coordinating and Bioinformatics Unit. The MMPC/AMDCC CBU will be responsible for providing administrative and bioinformatics support for both consortia.

2. Research Support Activities

The MMPC/AMDCC Coordinating and Bioinformatics Unit (CBU) will be a resource that is shared by the Mouse Metabolic Phenotyping Centers (MMPCs; http://www.mmpc.org) and the Animal Models of Diabetic Complications Consortium (AMDCC; http://www.amdcc.org). Activities to be undertaken by the CBU include: 1) providing clerical and administrative support, 2) maintaining and managing central databases, 3) funding and overseeing financial management of consortium-related expenses, including the MMPC Pilot & Feasibility Program, 4) updating and maintaining MMPC and AMDCC internet and intranet websites, and 5) promoting each consortium via advertising and through facilitating collaborative efforts.

2.A. CBU Administrative Functions

2.A.1. CBU activities common to MMPC and AMDCC consortia

• Facilitating cohesive and collaborative interactions within the MMPC and AMDCC by organizing, funding, and providing minutes/reports of regularly scheduled meetings of the consortia and their advisors. It is expected that the CBU will coordinate and provide meeting support for semi-annual face-to-face meetings of each consortium, and will provide coordination and travel funds for annual meetings of their respective External Advisory Boards (EAB) as outlined in Part II Sections I.3.B & I.3.C. The MMPC and AMDCC EABs currently consist of 7-10 members. A joint MMPC-AMDCC meeting should replace one of the semi-annual meetings for each consortium in project years 6 (2006), 8 (2008) and 10 (2010).

• Organizing monthly teleconferences of Executive Steering Committee meetings and as needed for other subcommittees; providing minutes and reports of Executive Steering Committee and EAB meetings; tracking and posting of minutes of regular meetings of MMPC Internal Advisory Committees on a members-only website;

• Curating and maintaining public websites for each consortium (http://www.mmpc.org; http://www.amdcc.org/) and providing logistical advice and support as-needed for maintaining individual consortium-related websites; development and maintenance of members-only websites for both the MMPC and AMDCC, including establishment and maintenance of an Internet-based mechanism for rapid data and document transmission and electronic communication among participants in the consortia and between the consortia and the NIH; development of methods and means to document and advertise consortial activities, including development and distribution of advertising materials for the consortia and any associated Pilot and Feasibility Programs; updating and posting of MMPC and AMDCC protocols, Guidelines and Policies, and any associated consortium-related documents as deemed necessary by MMPC and AMDCC oversight committees and NIH staff.

2.A.2. CBU activities unique to the MMPC

• Awarding subcontracts for projects to be supported through the MMPC Pilot and Feasibility Program, which provides for the development and validation of new technologies for mouse phenotyping. The solicitation, review, and selection of Pilot and Feasibility projects will be managed by individual MMPCs and the EAB. The CBU will also track and provide fiscal oversight for the Pilot & Feasibility program;

• Tracking of business activities and workflow at individual MMPCs; filing records of MTAs submitted with service requests; maintaining records of any formal collaborative agreements at the MMPCs; monitoring utilization of cores;

• Designing and implementing methods for evaluating the MMPC effort, such as a formal process for obtaining feedback from users. The CBU may also organize meetings or workshops for users of the MMPCs for the purpose of sharing information and data, obtaining feedback, training, exploring the need for new tests, or monitoring the value of a particular set of tests to the user community;

• Coordinating consortium activities across MMPCs, including collaborations with outside groups, optimization of services across Centers, preparation of consortium publications on best practices or standardized procedures, training programs, etc.; curation of the MMPC catalog.

2.A.3. CBU activities unique to the AMDCC

• Organizing periodic meetings or workshops for the purpose of bringing AMDCC investigators together with the community of diabetic complications researchers. Such meetings may be used to facilitate information and data exchange among participants and to promote collaborative research ventures;

• Coordinating activities across the AMDCC consortium, including collaborations with outside groups, preparation of consortium publications on best practices or standardized procedures, etc.

2.B. CBU Bioinformatics Functions

• Curation, maintenance, and expansion of the MMPC and AMDCC databases as needed to accommodate a centralized and comprehensive internet-based database of important phenotypic information acquired by each consortium. Additional funds are allotted in the initial year of the award to support necessary equipment or personnel to upgrade and harmonize databases as required;

• Tracking and facilitating movement of data from MMPC sites and AMDCC sites into respective central data repositories; providing training for personnel (including on-site visits) as needed to ensure rapid and timely data depositions; providing advice and guidance on use of the database to investigators within and outside the consortia;

• Additional bioinformatics functions as proposed in the application or as required by the MMPC or AMDCC Executive Steering Committee and EAB.

2.C. CBU Personnel and Budget

The CBU should have a Director, a full-time administrator, and additional personnel as needed for its proposed activities. In addition, the CBU should request up to $300,000 per year for MMPC Pilot and Feasibility projects to be funded via subcontracts from the CBU.

Consortium Activities and Administrative Structure

The CBU will provide administrative coordination and bioinformatics support for MMPC and AMDCC consortia. The MMPC Consortium will consist of 4-5 cooperating Phenotyping Centers (MMPCs) and this shared CBU; it will be guided by an MMPC Executive Steering Committee and External Advisory Board. The AMDCC will consist of a Mouse Generation and Husbandry Core, multiple Pathobiology sites and this shared CBU; it will be guided by an AMDCC Executive Steering Committee and External Advisory Board.

3.A. Consortium Activities and Responsibilities

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

3.B. Executive Steering Committee

The Principal Investigator of the CBU must agree to participate in the Executive Steering Committee of each consortium. These Executive Steering Committees meet monthly by teleconference and twice each year in person to encourage information exchange within the consortia. For the MMPC, the Executive Steering Committee will consist of the MMPC Center Directors, the PI of the Coordinating and Bioinformatics Unit, NIDDK and NHLBI Project Scientists, the NIDDK Project Official, and other Core Directors and MMPC personnel as needed. For the AMDCC, the Executive Steering Committee will consist of PIs from each of the AMDCC Pathobiology Sites, the Director of the Mouse Generation and Husbandry Core, the PI of the Coordinating and Bioinformatics Unit, NIH Project Scientists, and the NIDDK Project Official. The Chairs will be chosen from among the Center Directors (MMPC) or PIs of Pathobiology Sites (AMDCC), respectively, 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 Committees 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 Committees 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.

3.C. External Advisory Board (EAB)

The Principal Investigator of the CBU must indicate his/her intention to be responsive to recommendations provided by an independent External Advisory Board (EAB). The MMPC and AMDCC EABs will meet annually in conjunction with one of the semi-annual meetings of the Executive Steering Committee of each consortium. At these annual meetings the EAB 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 EABs will be nominated by the Executive Steering Committees of the MMPC and AMDCC consortia, in collaboration with the NIDDK and participating institutes, and will be invited by the NIH. A chairman for the MMPC EAB and AMDCC EAB will be chosen from among the 4-5 members of their respective EABs, 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 EAB and the EAB chair hold one vote each. The Executive Steering Committees of each consortium will discuss implementation of EAB recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to their respective EABs.

1. Mechanism(s) of Support

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

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U24 is a cooperative agreement award mechanism used to support research projects contributing to improvement of the capability of resources to biomedical research. In the cooperative agreement mechanism, the Principal Investigator 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". This initiative solicits applications for a CBU to support years 5-10 of the AMDCC and MMPC projects. Plans to continue beyond year 10 will depend on success, opportunity and needs in the mouse diabetes, diabetes complications, and obesity research community, and the availability of funds.

2. Funds Available

The NIDDK intends to commit approximately $1 million in FY 2006 to fund one new award for the MMPC/AMDCC CBU in response to this RFA. An applicant may request a project period of up to five years and a budget of up to $1 million total costs in FY2006 and $750,000 total costs per year for years 2-5. Of this amount $300,000 direct costs is reserved for an MMPC pilot and feasibility research program. The anticipated start date for the application funded in response to this RFA is September 01, 2006.

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.

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Domestic Institutions

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.

2. Cost Sharing or Matching

Cost-sharing or matching is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Investigators may submit only one application for this RFA.

1. Address to Request Application Information

The 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) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. 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 on line 2 of the face page of the application form and the YES box must be checked.

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 18, 2005
Application Receipt Date(s): November 16, 2005
Peer Review Date: February March 2006
Council Review Date: May 31-June 01, 2006
Earliest Anticipated Start Date: September 01, 2006

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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 at the beginning of this document.

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Review Branch
National Institute of Diabetes 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 research grant applications 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.
Review Branch
National Institute of Diabetes 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

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive applications will not be reviewed and will be returned.

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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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 http://grants.nih.gov/grants/policy/policy.htm. (See also Section VI.3. Reporting).

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Content and order of information to be provided in applications is described below. Failure to comply with these instructions will result in return of the application without review.

The Research Plan in applications for the MMPC/AMDCC Coordinating and Bioinformatics Unit (CBU) should include the indicated items in the following order.

General Goals and Background
Progress Report (if applicable)
Administrative Support

• Descriptive Abstract
• Key Personnel
• Administrative Objectives
• Administrative functions, including plans for providing consortium coordination, website development and curation, P&F program administration and financial tracking

Bioinformatics Support

• Descriptive Abstract
• Key Personnel
• Bioinformatics objectives and functions, including plans for design, maintenance and curation of databases, networking and bioinformatics support
• Benefit to MMPC from CBU
• Benefit to AMDCC from CBU
• Coordination and synergy between MMPC and AMDCC bioinformatics

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

1. Criteria

The MMPC/AMDCC CBU will be reviewed using both standard and additional criteria as outlined in Sections V.2 and V.2.A.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

The following additional criteria can be used for review of the MMPC/AMDCC Coordinating and Bioinformatics Unit.

Will the CBU be able to:

• Provide administrative support for consortium meetings, reports, advertising, etc.?
• Provide subcontracts to fund MMPC Pilot and Feasibility Projects in an efficient manner?
• House, maintain, and curate the MMPC and AMDCC websites and intranet?
• Provide maintenance, continued development, and aid to populate the MMPC and AMDCC database(s)

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research will be considered. However, the priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data-sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data-sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 notice of grant award. 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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.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 (U24) , 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator of the MMPC/AMDCC Coordinating and Bioinformatics Unit will have the primary responsibility for planning, organizing and carrying out administrative and bioinformatics functions to serve the MMPC and AMDCC consortia, making subcontracts to fund MMPC Pilot and Feasibility projects selected by the MMPC Executive Steering Committee and External Advisory Board, maintenance and design of the MMPC and AMDCC websites and databases as necessary, and service on Executive Steering Committees of both consortia.

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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NIH Project Scientist will participate as a voting member of the MMPC or AMDCC Executive Steering Committee, and will invite members of the External Advisory Boards to serve. The NIH Project Scientist will help plan and carry out consortium activities, and will participate in all reports. He/She will act as a liaison between the MMPC or the AMDCC and the NIH.

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

The CBU will provide administrative coordination and bioinformatics support for MMPC and AMDCC consortia. The MMPC Consortium will consist of 4-5 cooperating Phenotyping Centers (MMPCs) and this shared CBU; it will be guided by an MMPC Executive Steering Committee and External Advisory Board. The AMDCC will consist of a Mouse Generation and Husbandry Core, multiple Pathobiology sites and this shared CBU; it will be guided by an AMDCC Executive Steering Committee and External Advisory Board.

Consortium Activities and Responsibilities

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

Executive Steering Committee

The Principal Investigator of the CBU must agree to participate in the Executive Steering Committee (ESC) of each consortium. These Executive Steering Committees meet monthly by teleconference and twice each year in person to encourage information exchange within the consortia. For the MMPC, the Executive Steering Committee will consist of the MMPC Center Directors, the PI of the Coordinating and Bioinformatics Unit, NIDDK and NHLBI Project Scientists, the NIDDK Project Official, and other Core Directors and MMPC personnel as needed. For the AMDCC, the Executive Steering Committee will consist of PIs from each of the AMDCC Pathobiology Sites, the Director of the Mouse Generation and Husbandry Core, the PI of the Coordinating and Bioinformatics Unit, NIH Project Scientists, and the NIDDK Project Official. The Chairs will be chosen from among the Center Directors (MMPC) or PIs of Pathobiology Sites (AMDCC), respectively, and may rotate annually.

The purpose of the Executive Steering Committees 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 Committees 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 Advisory Board (EAB)

The Principal Investigator of the CBU must indicate his/her intention to be responsive to recommendations provided by an independent External Advisory Board (EAB). The MMPC and AMDCC EABs will meet annually in conjunction with one of the semi-annual meetings of the Executive Steering Committee of each consortium. At these annual meetings the EAB 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 EABs will be nominated by the Executive Steering Committees of the MMPC and AMDCC consortia, in collaboration with the NIDDK and participating institutes, and will be invited by the NIH. A chairman for the MMPC EAB and AMDCC EAB will be chosen from among the 4-5 members of their respective EABs, 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 EAB and the EAB chair hold one vote each. The Executive Steering Committees of each consortium will discuss implementation of EAB recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to their respective EABs.

2.A.4. Arbitration 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 arbitration. An Arbitration 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 arbitration procedure in no way affects 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 PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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
FAX: (301) 480-3503
Email: ka136s@nih.gov

Christian J. Ketchum, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 647
Bethesda, MD 20892-5458
Telephone: (301) 402-1411
FAX: (301) 480-3510
Email: ck228s@nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Review Branch
National Institute of Diabetes 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:

Randi Freundlich, R.D.
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 724
Bethesda , MD 20892-5456
Telephone: (301) 594-8825
FAX: (301) 480-3504
Email: rf160d@nih.gov

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.

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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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/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.

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.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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 or Health Systems Agency review. 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.

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