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://www.niddk.nih.gov)
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Mouse Metabolic Phenotyping Centers Consortium

Announcement Type
Renewal of RFA-DK-00-014.

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

Request For Applications (RFA) Number: RFA-DK-05-008

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.847, 93.849

Key Dates
Release Date: June 8, 2005
Letters of Intent Receipt Date(s): October 14, 2005
Application Receipt Dates(s): November 16, 2005
Peer Review Date(s): Feb - Mar 2006
Council Review Date(s): May 31–June 01, 2006
Earliest Anticipated Start Date: July 01, 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: November 17, 2005

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
   2. Research Topics
   3. Consortium Activities and Administrative Structure
   4. Description of a Phenotyping Center
   5. Program Income
   6. Data Ownership and Authorship
   7. Terms and Agreements
   8. Description of the Coordinating and Bioinformatics Unit (CBU)

 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

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Background

There is a growing need for careful characterization of new mouse models of chronic metabolic diseases, including diabetes and obesity. The Mouse Metabolic Phenotyping Centers (MMPC; http://www.mmpc.org) respond to this need by providing an array of sophisticated phenotyping services to the mouse research community. Gene targeting technologies and large-scale mutagenesis efforts have produced numerous mouse lines with well-defined DNA structural changes. Candidate genes for diabetes, diabetes complications, obesity and other disorders of metabolism have been identified, and modified mice are now being used to dissect the genetics, basic mechanisms, and physiology underlying many of these conditions. 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 MMPC is currently a basic science 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). 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 been charged with 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 young investigators or established investigators from other scientific fields in diabetes and obesity research; and 5) work closely with the MMPC/AMDCC 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 procedures to characterize metabolism, body composition, energy balance, feeding behavior, activity, organ function, tissue pathology, and other physiologic, anatomic or pathological alterations that may occur in mice. The Centers work together to provide a broad range of phenotyping tests. In the next project period, the MMPCs will work closely with the NIH-funded Animal Models of Diabetic Complications Consortium (AMDCC, http://www.amdcc.org/) which generates and characterizes animal models of diabetic neuropathy, nephropathy, retinopathy, uropathy and macrovascular diseases. The focus of the MMPC consortium is on experiments that characterize the living animal, and on technologies that are valuable for understanding metabolism and physiology, but that are not yet 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 their various mice for detailed metabolic and physiologic phenotyping beyond what would be possible or cost-effective in their individual laboratories.

In addition to the fee-for-service phenotyping centers, the MMPCs currently support an administrative infrastructure including a database for tracking business activity, a website for submission of electronic requests for services, and a collaborative research database of test results. These resources were designed to coordinate efforts within the consortium and to provide a unique phenotyping data resource for the research community. In 2006, a Coordinating and Bioinformatics Unit (CBU) will be added to house these activities and to coordinate meetings, a Pilot and Feasibility (P&F) research program, and other consortium activities. This facility will be shared by the MMPC and the AMDCC, and will be funded through a separate initiative.

Each application may request funds for one MMPC Phenotyping Center.

2. Research Topics

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

3. Consortium Activities and Administrative Structure

The MMPC Consortium will consist of 4-5 cooperating phenotyping centers (MMPCs) and a Coordinating and Bioinformatics Unit (CBU), with guidance provided by an Executive Steering Committee and an External Advisory Board. 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 an Internal Steering Committee, and will consist of an Administrative Core, an Animal Core, one or more Phenotyping Cores, and a Research and Development program. These activities are described in Section 4 below. The CBU will provide administrative coordination and bioinformatics support for the consortium. It will be shared with the AMDCC and will be competed through a separate RFA. CBU activities are described briefly in Section 8 below.

3.A. Consortium Activities and Responsibilities

The Principal Investigator and co-PIs must agree to be active participants in consortium-wide activities as deemed necessary by appropriate oversight committees. Such activities may include development of consortium publications describing phenotyping services and best practices; coordination and harmonization of service offerings between MMPC sites; identification of new services; assisting the CBU in development and organization of MMPC users meetings.

3.B. Executive Steering Committee

The Principal Investigator and co-PIs must agree to participate in an Executive Steering Committee that will meet monthly by teleconference and twice each year in person to encourage the exchange of information among participating MMPC Consortium sites. The Executive Steering Committee will consist of the MMPC Center Directors, the Director of the Coordinating and Bioinformatics Unit, the NIDDK and NHLBI Project Scientists , the NIDDK Project Official, and other Core Directors and MMPC personnel as needed. The Chair will be chosen from among the Center Directors. 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 of the MMPC and signing off on Grant Progress Reports. The purpose of the Executive Committee will be to discuss and evaluate concerns and cooperative activities of the MMPC at-large. The Executive Steering Committee may form and charge other subcommittees as needed (for example in the areas of administration, bioinformatics, new technologies, or mutagenesis screening). A major goal of Executive Steering Committee meetings is to facilitate progress by providing a forum for sharing skills, ideas, technology, data, and biological reagents among participating MMPC sites. At the meetings, participants will also discuss quality assurance, bioinformatics, project coordination, protocol consistency, test comparisons across background strains or across Centers, and training. If voting is necessary for an action item, individual Centers and the NIDDK hold one vote each. The Executive Committee will discuss and evaluate MMPC Subcommittee/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 for existing cores, as well as new cores, collaborative projects, and the pilot and feasibility program. The Executive Steering Committee and External Advisory Board will decide in those rare instances if new tests should be exempted from the fee-for-service model, or should be allowed to be conducted routinely as collaborative research (as described in Part II, Section I, Subsections 5 and 6).

3.C. External Advisory Board

MMPC PIs must indicate their intention to be responsive to recommendations provided by an independent External Advisory Board (EAB). Members of the EAB will be nominated by the Executive Steering Committee in collaboration with the NIDDK and NHLBI, and will be invited by the NIDDK and NHLBI. APPLICANTS SHOULD NOT SUGGEST NAMES FOR ADVISORY BOARD MEMBERS. A chairman will be chosen from among the 4-5 members, 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. The EAB will meet annually in conjunction with one of the semi-annual meetings of the Executive Steering Committee to review interim progress of the MMPC consortium and provide an annual report and recommendations to NIDDK, NHLBI and to the Executive Steering Committee. The Executive Steering Committee will discuss implementation of recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to the EAB.

3.D. Collaboration with the AMDCC

MMPC PIs must indicate their willingness to work with the AMDCC to provide state-of-the-art services for phenotyping diabetic complications. Such services may be concentrated at a single MMPC site, and a focus on tests for diabetic complications is NOT required in order to be responsive for this RFA.

4. Description of a Phenotyping Center (MMPC)

4.A. Phenotyping and Analysis Cores

The most important aspect to be considered in preparing and evaluating an application for an MMPC are the proposed Phenotyping and Analysis Cores. Each Center will have one or more phenotyping cores headed by a Core Director, where tests will be performed on submitted mouse models. Core personnel will design or adapt, standardize and validate a variety of tests to be conducted on living animals or body fluids and 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. Emphasis will be placed on centers providing a broad range of tests and expertise, on centers using technologies for the study of live animals, on unique and powerful tests that are difficult, require specialized equipment, or are not widely distributed, and on those that provide tests of special and essential value to the diabetes and obesity mouse research community. Centers may also accept tissue samples and body fluids for specific analyses. Phenotyping centers should be capable of analyzing multiple phenotypes using a breadth of assays, with particular value placed where multiple analyses can occur on single models or on individual mice. 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 methodologies, technologies, statistical analytical tools and costs, and describe the limitations of the approaches. Applicants must indicate the number of animals that could be studied each year for each test. Potentially interesting mice will have been developed on a variety of genetic backgrounds. Therefore characterization 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. In addition, MMPCs with an emphasis on phenotyping for diabetic complications may be asked by the AMDCC to provide limited tests for non-mouse models of disease. This service will be made available by request only, and must be preapproved by MMPC and AMDCC Steering Committees. 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 expertise in some aspect of metabolism, diabetes, diabetic complications, obesity, etc. It is expected that each center will work closely with the others through the Executive Steering Committee to take full advantage of these strengths and provide the best possible range of tests. 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:

4.B. 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 the R&D plan will provide new protocols that may be adopted into the Center's existing services as deemed appropriate by the MMPC Executive Steering Committee. 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 technologies.

4.C. 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 found at http://www.mmpc.org/animals.html, 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 cage capacities. Control, test, and sentinel animals should be shipped to MMPCs, and it is not anticipated that animals will be returned to the originating institution.

4.D. MMPC Steering Committee

The Administrative Core will establish an internal 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/AMDCC CBU and NIH staff. The Steering Committee will oversee the evaluation of applications for services, monitor progress of the MMPC cores, will approve new tests, oversee the evaluation of P&F applications, determine when test fees should be waived (new PIs, P&F projects, etc.) and participate in other ways as necessary.

4.E. Administrative Core

Whereas the significance and quality of the MMPC is defined by its phenotyping cores, an efficient administrative core is necessary to ensure the MMPC's vitality and success. In consultation with the MMPC/ AMDCC 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:

5. 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 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.

It is likely that certain tests cannot be easily adapted to the fee-for-service model, either because they are particularly expensive in time or supplies, or because they require specialized Center expertise to optimize experimental design for each animal model, or to interpret data via sophisticated mathematical models, etc. Such tests may be particularly valuable and therefore appropriate for an MMPC. Such tests may be exempted from the requirement for a fee-for-service by the NIDDK RFA review committee, or by the Executive Steering Committee and External Advisory Board. Applicants should clearly indicate tests that should be considered for exemption, and justify the need for such an exemption.

6. Data Ownership and Authorship

The MMPCs are meant to provide a service at below cost to the research community, but 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.

Just as a certain category of tests may be valuable but inappropriate for a fee-for-service model, these same tests may be best pursued as collaborations rather than just providing the limited planning and advice that would normally be required. Such tests may be allowed as collaborations by the NIDDK RFA review committee or by the Executive Steering Committee and External Advisory Board. Applicants should clearly indicate tests that should be considered, and justify the need for such an exemption. Exemptions will be allowed on the basis of the potential value of the test to the community and the need for an unusually high level of intellectual and scientific involvement by Center staff. It is hoped that there will be relatively few tests in this category, and that R&D efforts will make them more routine.

7. Terms and Agreements

Applicants for MMPCs should address the following. 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 should include a plan for cost recovery through a fee-for-service structure, and should indicate how program income will be used to enhance MMPC activities. 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. MMPCs will participate in a Pilot and Feasibility Program and in the Executive Steering Committee. Centers must conduct all tests on three typical background strains as deemed appropriate by the Executive Steering Committee and the EAB. 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/AMDCC 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).

8. Description of the MMPC Coordinating and Bioinformatics Unit (CBU)

The MMPC Coordinating and Bioinformatics Unit (CBU) will be shared with the Animal Models of Diabetic Complications Consortium (AMDCC, http://www.amdcc.org) and will be competed through a separate RFA. 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 P&F Program and consortium related expenses, 4) updating and maintaining the MMPC internet and intranet websites, and 5) promoting the consortium via advertising and through facilitating collaborative efforts.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U24 research resource grant award mechanism. 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. 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 years 6-10 of the MMPC project, and plans to continue will depend on success, opportunity and needs in the mouse diabetes and obesity research community, and the availability of funds.

2. Funds Available

The NIDDK and NHLBI intend to commit approximately $4.2 million dollars in FY 2006 to fund 4- 5 new and/or competing continuation awards for Phenotyping Centers in response to this RFA. An applicant for a phenotyping center may request a project period of 5 years and up to $600,000 direct costs per year.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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.

Section IV. Application and Submission Information

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) 435-0714, 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.

The research plan for MMPC phenotyping center can be up to 40 pages in length.

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

Letters of Intent Receipt Date(s): October 14, 2005
Application Receipt Dates(s): November 16, 2005
Peer Review Date(s): Feb - Mar 2006
Council Review Date(s): May 31–June 01, 2006
Earliest Anticipated Start Date: July 01, 2006
Additional Information To Be Available Date (Url Activation Date): N/A

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 at the beginning of this document.

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 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 PHS 398 research grant application instructions and forms as described above. 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 Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 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. Personal deliveries of applications are no longer permitted.

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 and NHLBI. 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 (presented within page limits indicated in Section IV.2) is described below. Failure to comply with these instructions will result in return of the application without review.

TITLE: Applicants should indicate in the title the application is for an MMPC-phenotyping center.

6.A. The Research Plan in applications for MMPC phenotyping centers should include the indicated items in the following order.

• Descriptive Abstract
• Core Director(s) and Key Personnel
• Budget with justifications
• Objectives of the phenotyping/analysis core
• Preliminary Studies, if applicable
• Core functions, including protocols and quality control
• Projected utilization and workflow
• Projected Program Income
• Benefits from core – impact on research
• Research and Development projects
• Description of pertinent facilities and institutional commitment

• Descriptive Abstract
• Core Director and Key Personnel
• Core budget with justifications
• Objectives of the core
• Core function, including quality control
• Benefits from core
• Description of pertinent facilities and institutional commitment

• Descriptive Abstract
• Core Director and Key Personnel
• Core budget with justifications
• Presentation of the administrative structure
• Relationship and lines of authority and sanction by appropriate institutional officials
• Committee structures (include committee for oversight of the pilot and feasibility program)
• Administrative plan
• Service plan
• Business plan
• Website development and curation plan
• Pilot and Feasibility Program
• Training Program (if appropriate)
• Description of pertinent facilities and institutional commitment

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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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.

Section V. Application Review Information

1. Criteria

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

The MMPC phenotyping centers will be reviewed using criteria in Section V.2. below.

The following will be considered in making funding decisions:

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:

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.

1. 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?

2. 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?

3. 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?

4. 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)?

5. 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 review considerations apply to all new and competing continuation MMPC Phenotyping Center Applications. Do the proposed tests fill a need present in the diabetes and obesity research communities, and will they characterize a reasonable range of phenotypes, provide information that would otherwise be unavailable to most laboratories, or be more cost-effective to conduct centrally? Is the necessary technical and analytical expertise available? Does the application demonstrate potential for in-house development of important new tests and technologies that will expand the scope and quality of the available tests? Do existing centers show clear evidence of intent to implement a charge-back structure to support expanded and/or evolving center activities? Does the institution have the capacity to receive, house and care for an adequate number of mice?

The following evaluation criteria will be used to assess the progress of competing continuation MMPC phenotyping center applications, and were developed by the current MMPC Executive Steering Committee and External Advisory Board. Competing applications should show growth in the following areas:

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 (such as diabetic complications), may be difficult and low throughput but provide important results, may deliver rare technology to a wider circle of researchers than would otherwise have access to it, or be able to uncover subtle metabolic defects. Such tests may require much more time and staff input, and it may be more appropriate for MMPC staff to be represented as coauthors on resultant publications.

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. The priority score should not be affected by the evaluation of the budget.

Exemptions from fee-for-service or permission for routine collaborations: Whether it is appropriate for some tests to be exempted from the fee-for-service requirement, or be allowed to be done routinely as collaborations with researchers seeking services from the MMPCs (so that data is owned jointly by the MMPC and the researcher). This is described in Part II, Section I, Subsections 5 and 6. The priority score should not be affected by this evaluation.

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.

Applications will be reviewed for adequate sharing of resources, which is expected to be predominantly through fee-for-service phenotyping tests of submitted mice, but may also include training programs, distribution of reagents, etc. 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

Section VI. Award Administration Information

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- Research Resource Grant), 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 an MMPC phenotyping center will have the 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 Director, 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 make sure 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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

He/She will participate as a voting member of the MMPC Executive Steering Committee, and will invite members of the External Advisory Board to serve. The NIH Project Scientist will help plan and carry out MMPC consortium activities, and will participate in all reports. He/She will act as a liaison between the MMPC and the NIH.

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

The NIDDK Project Official is the NIDDK staff person responsible for reviewing annual progress of the MMPC, normal programmatic stewardship, and signing off on Grant Progress Reports.

2.A.3. Collaborative Responsibilities

The MMPC Consortium will consist of 4-5 cooperating phenotyping centers (MMPCs) and a Coordinating and Bioinformatics Unit (CBU), with guidance provided by an Executive Steering Committee and an External Advisory Board. 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 an Internal Steering Committee, and will consist of an Administrative Core, an Animal Core, one or more Phenotyping Cores, and a Research and Development program. The CBU will provide administrative coordination and bioinformatics support for the consortium. It will be shared with the AMDCC.

Consortium Activities and Responsibilities

The Principal Investigator and co-PIs must agree to be active participants in consortium-wide activities as deemed necessary by appropriate oversight committees. Such activities may include development of consortium publications describing phenotyping services and best practices; coordination and harmonization of service offerings between MMPC sites; identification of new services; assisting the CBU in development and organization of MMPC users meetings.

Executive Steering Committee

The Principal Investigator and co-PIs must agree to participate in an Executive Steering Committee that will meet monthly by teleconference and twice each year in person to encourage the exchange of information among participating MMPC Consortium sites. The Executive Steering Committee will consist of the MMPC Center Directors, the Director of the Coordinating and Bioinformatics Unit, the NIDDK and NHLBI Project Scientists , the NIDDK Project Official, and other Core Directors and MMPC personnel as needed. If voting is necessary for an action item, individual Centers and the NIDDK hold one vote each. The Chair will be chosen from among the Center Directors.

The purpose of the Executive Steering Committee will be to discuss and evaluate concerns and cooperative activities of the MMPC at-large. The Executive Steering Committee may form and charge other subcommittees as needed (for example in the areas of administration, bioinformatics, new technologies, or mutagenesis screening). A major goal of Executive Steering Committee meetings is to facilitate progress by providing a forum for sharing skills, ideas, technology, data, and biological reagents among participating MMPC sites. At the meetings, participants will also discuss quality assurance, bioinformatics, project coordination, protocol consistency, test comparisons across background strains or across Centers, and training. The Executive Committee will discuss and evaluate MMPC Subcommittee/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 for existing cores, as well as new cores, collaborative projects, and the pilot and feasibility program. The Executive Steering Committee and External Advisory Board will decide in those rare instances if new tests should be exempted from the fee-for-service model, or should be allowed to be conducted routinely as collaborative research. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

External Advisory Board

MMPC PIs must indicate their intention to be responsive to recommendations provided by an independent External Advisory Board (EAB). Members of the EAB will be nominated by the Executive Steering Committee in collaboration with the NIDDK and NHLBI, and will be invited by the NIDDK and NHLBI. A chairman will be chosen from among the 4-5 members, 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. The EAB will meet annually in conjunction with one of the semi-annual meetings of the Executive Steering Committee to review interim progress of the MMPC consortium and provide an annual report and recommendations to NIDDK, NHLBI and to the Executive Steering Committee. The Executive Steering Committee will discuss implementation of recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to the EAB. This ESC will oversee the MMPC website and database and act as secondary review for the Pilot and Feasibility Program. They will work together to establish training programs and write consortium publications as appropriate. The Executive Steering Committee and External Advisory Board will decide in those rare instances if new tests should be exempted from the fee-for-service model, or should be allowed to be conducted routinely as collaborative research (as described in Part II, Section I, Subsections 5 and 6).

Collaboration with the AMDCC

MMPC PIs must indicate their willingness to work with the AMDCC to provide state-of-the-art services for phenotyping diabetic complications. Such services may be concentrated at a single MMPC site.

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.

In addition to normal elements of Form 2590, noncompeting continuation MMPC phenotyping center applications should include the following:

  1. Prior Year Budget (actual expenditures and income, salaries)
    Upcoming Year Budget (projected expenditures and income, salaries)
  2. List of personnel, biosketches for new personnel
  3. List of online tests and progress toward new tests, etc.
  4. Core Use: How many animals tested using each test/core
  5. Tabulation of submitted/accepted/completed mouse models (breakdown of in house vs. outside)
  6. Progress/Pitfalls in consortium activities (web page/ database/ partnership activities/ standardization/ development of protocols/ animal husbandry concerns/ etc.)
  7. Research Projects: progress
  8. Publications that acknowledge the U24 award
    a. authored by Center Investigators
    b. authored by external investigators using U24 as service
  9. Summary of P&F projects funded & brief summary of progress
  10. Future plans
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, Rm. 795
Bethesda, MD 20892-5460
Telephone: (301) 451-8048
FAX: (301) 480-3503
Email: ka136s@nih.gov

Chris Ketchum, PhD
Division of Kidney, Urology and Hematology
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 647
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
Fax: (301) 480-3510
Email: ck228s@nih.gov

Cristina Rabadan-Diehl, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Rm. 10186
Bethesda, MD 20892-7164
Phone: 301-435-0550
Fax: 301-480-2858
Email: cr225k@nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3. Financial or Grants Management Contacts:

Randi Freundlich, R.D.
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 723
Bethesda , MD 20892-5456
Telephone: (301) 594-8825
FAX: (301) 480-3504
Email: rf160d@nih.gov

Teresa Farris Marquette
Section Chief, Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge II, Rm. 7152
Bethesda, MD 20892
Phone: 301-435-0172
Fax: 301-480-3310
Email: tm275a@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. 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.

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-02-005.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. Applications that do not provide this information will be returned without review.

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 PA 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.

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. 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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