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
This FOA is developed as an NIH Roadmap initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate in roadmap initiatives. The FOA will be administered by the National Center for Research Resources (http://www.ncrr.nih.gov/ on behalf of the NIH.

Title: Renewal of the National Technology Centers for Networks and Pathways Program (U54)

Announcement Type
This is a reissue of RFA-RM-04-019.

Request For Applications (RFA) Number: RFA-RM-08-021

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release Date: July 15, 2008
Letters of Intent Receipt Date: September 28, 2008   
Application Receipt Date: October 28, 2008   
Peer Review Date(s): February - March 2009   
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009   
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: October 29, 2008   

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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

Rationale for the Program:

Limitations of proteomics technologies often force investigators to treat dynamic systems as artificially static. As with early photography, current approaches to proteomics involve long exposures that capture broadly defined “images” such as “normal vs. diseased” or “the yeast interactome.”  We are largely blind to the dynamics of systems we know are not static but which must be treated as such for the time being because of inadequate tools.  Transient interactions, rapid changes in protein activity or location, and post-translational modifications control critical regulatory steps in biology, yet they are like a bird flying through the frame of a carefully composed long exposure: invisible.

New strategies complementary to conventional proteomics are necessary to help us determine the rapid, dynamic changes that control physiology. The National Technology Centers for Networks and Pathways program (TCNPs) (http://nihroadmap.nih.gov/buildingblocks/technologycenters) creates technologies to measure the dynamics of protein interactions, modifications, translocation, expression, and activity, with temporal, spatial, and quantitative resolution.  The program is intended to bridge the quantitation and interaction aspects of proteomics, breaking out of the artificially static view of complex systems. The TCNP program was envisioned specifically to complement conventional proteomics programs at NIH, integrating proteomics with cell biology and biophysics, with an enhanced emphasis on novel approaches not substantially supported in other programs.

Scientific Focus of the Program:

Proteomics experiments have consistently been characterized as falling into two broad classes, either directed at defining the physical interactions of proteins, or concerned with characterizing changes in the expression of proteins corresponding to internal or external perturbations of cells or systems. The methodological issue that has largely driven this distinction is the inherent difficulty of quantitation of individual molecules in complex systems. The distinction is artificial, since in either instance, the goal is to define the roles and functions of proteins in inherently dynamic systems, whether considered as networks of interactions or steps in a biochemical pathway.

As the results of biophysical experiments are assembled into coherent models of these systems, temporal, spatial, and quantitative resolution all become increasingly critical factors. While substantial and rapid progress has been made over the past decade in the development of analytical technologies for proteomics, the greatest successes have overwhelmingly resided in the realm of tightly bound protein complexes.  In this case, definition of protein identity and interaction are the two critical analytical tasks, addressed through the creative application of molecular and cellular biological methods, often followed by separation and mass spectrometry.  While these basic technologies arguably underlie all of proteomics, and still present significant challenges, a concentrated effort is needed to develop and integrate a series of technologies orthogonal to these fundamental tools. These additional technologies should address the problems of temporal and spatial dynamics of protein function and interaction, and they should do so quantitatively.  Significant NIH resources continue to be directed to fundamental separation and identification technologies. This program is meant to be largely orthogonal to those efforts, intersecting with them and utilizing them, but not investing significantly in further development of those areas.

It will be impossible to fully define dynamic biological systems strictly on the basis of proteomic data alone. Protein interaction, modification, translocation and expression level will need to be considered in the context of gene transcription and metabolism. The same necessity for quantitative, temporal, and spatial resolution applies to these analyses. Acquisition and integration of these data are significant challenges, and substantial difficulties remain with respect to the fundamental tasks of profiling and cataloging biomolecules in complex systems. While efforts continue in development of these fundamental technologies, it is important that parallel efforts build technologies directed specifically to the dynamics of complex systems. To facilitate the development of these technologies and build infrastructure for support of biomedical research, the NIH is supporting National Technology Centers for Networks and Pathways.

This Funding Opportunity Announcement (FOA) is intended to encourage development of highly sensitive tools to measure the dynamics of quantity, activity, translocation, or interactions of protein molecules in cells. Preference will be given to applications that have promise to be quantitative, to capture information at timescales relevant to the study of pathways and networks, and to be applied at subcellular resolution. It is anticipated that approaches will be valuable which can be scaled, facilitating capture of information about a comprehensive set of molecules or with the potential for broad, flexible application to a range of specific molecules.  These issues are deliberately discussed with respect to fundamental analytical challenges, rather than in relation to specific technologies, in order to emphasize the overriding importance of surmounting these obstacles, irrespective of the analytical strategy adopted to pursue those solutions. This solicitation encourages unconventional or alternative approaches as a balanced portion of the overall center effort.

Collaboration with other TCNP centers and independent biomedical researchers:

Centers supported by the TCNP program are independent, but are also expected to work collaboratively with other TCNPs. The primary goal of the program is to develop instrumentation, biophysical methods, reagents, and infrastructure for temporal and spatial characterization of complex biochemical pathways and networks of protein interactions.  Centers are also expected to collaborate with biomedical researchers through several mechanisms, providing a synergistic push-pull between technological advancement and biomedical problem solving.  In addition, the centers are tasked with providing broad access to the technologies, methods, and reagents they develop, as well as providing appropriate interdisciplinary academic and peer training for biomedical researchers.

The scope of the dynamics problem is very broad. Each center is expected to integrate multiple approaches to create a coherent biological, analytical, and informatics strategy, but it is expected that each will focus on different technologies and systems, with corresponding strengths.  Cooperation among the centers should allow them to broaden their scope and complement one another, with a correspondingly greater impact on biomedical research.

The TCNPs will focus on technology development, but three features of the program will ensure that the technology developed can be applied to relevant biological problems. First, each TCNP is encouraged, though not required, to select a biological focus or model system that will provide a thematic focus or context for technology development. Second, each TCNP will support a set of Driving Biological Projects (DBPs), which will provide an internal biological context for technology development. Third, a separate program announcement solicits applications for additional partnerships between individual investigators and these centers (PA-07-266: Networks and Pathways Collaborative Research Projects (R01), http://grants.nih.gov/grants/guide/pa-files/PA-07-266.html). These awards leverage and complement the research activities of the U54 centers in building comprehensive technologies for molecular networks and pathways research focused around biological processes, cellular organelles, organs, or diseases. These awards are made by participating NIH ICs and do not use Roadmap funds.

Structure of a TCNP:

It is expected that centers will incorporate multiple technologies and methods drawn from several areas that may include but are not limited to conventional proteomics, biophysics, cell and molecular biology, and computational biology. These domains should each inform the development of tools and methods in their counterpart areas. Accomplishing this goal in a climate of specialization demands a fundamentally collaborative approach. It is anticipated that investigators will assemble interdisciplinary teams from multiple laboratories.  It is not required that all participating investigators and laboratories be located either at a single institution or in the same local geographic area. However, because of the need for integration of technologies at a fundamental level, it is considered critical that participating investigators be in a position to work closely together in an iterative manner. These issues should be addressed in detail in the application. The project will be administered through the principal investigator and his/her institution.

All applications in response to this announcement will be evaluated primarily for the potential of the proposed activities to address the broad challenges discussed above, where it is clear that the technologies to be developed can be used to obtain the data required to elucidate and test dynamic functional models of a molecular network or pathway.  It is anticipated that these challenges are too broad for a single center to address comprehensively. Investigators will be expected to clearly define the scope of their technical and biological activities.  The funding mechanism for the TCNPs will be a U54 center. Each TCNP will be required to perform or facilitate six different core functions:

(1) conducting research in technology development, (2) establishing Driving Biological Projects (DBP) to allow biomedical researchers to interact with and drive research in the TCNP, (3) providing infrastructure to facilitate collaboration with biomedical researchers (hardware, software, and expertise as appropriate), (4) enhancing the training for biomedical researchers in tools and techniques developed in the center, (5) disseminating newly developed tools, reagents, and techniques to the broader biomedical research community, and (6) providing formal project leadership and management to ensure that these large centers achieve their goals within the 5 year funding lifetime of the award.

The technological research in core 1 will be the largest component of a TCNP, focused on development of cutting edge technology and methods for quantitative temporal and spatial characterization of protein network and pathway dynamics.  The technological R&D component consists of investigations that are at the cutting edge of the technological field with a goal of increasing its usefulness in biomedical research. A minimum of three technological research projects constitutes this section of the application. An element of high risk (high payoff) should be present in one or more of these projects and is appropriate for this component. It is expected that to make significant progress in this difficult area, revolutionary approaches will be necessary in many instances. When included as a component of technology development, a high-risk project should be well justified by the potential for correspondingly high returns, and should be presented in the context of an overall research plan, with appropriate discussion of the inherent risks and the alternative strategies available if the primary plan fails. Plans should balance risk within the overall goals of the project.

Conversely, in the case of technologies and methods that may be somewhat prosaic by comparison with the more revolutionary aspects of the research plan, care should be taken to describe their important contribution to the overall fabric of the Center’s activities. If for example a well-established analytical method is a critical component of the technology development plan, then the manner in which it is leveraged to support novel approaches should be well delineated. The integration of methods to create a coherent analytical strategy greater than the sum of its parts is a legitimate approach.  The technological R&D projects to be conducted must be presented in detail. For each project describe the background, objectives, rationale, methods and procedures, significance, and facilities available to conduct the project. If research activities involve support at more than one location through a consortium/contractual arrangement, the application should provide a separate description, detailed budget and budget justification for the consortium/contractual component(s).

In addition to the individual technology development projects, the interrelationships of these technologies should be described, as well as plans for maximizing connectivity and synergy both in the technologies and between participating groups. These discussions should be placed in the context of the overall strategic goals of the center’s research program.

Development of complex, integrated approaches to formulating networks and pathways will require contexts within which methods development can proceed. Investigators should consider selection of model systems (such as cellular processes, already characterized networks or pathways where the connections are mostly known but none of the dynamic information), or define a thematic biological research topic that will serve as a framework for the technological research and development activities of the center. It is suggested that an overarching biological theme can provide some coherence and focus for technology development, and it is encouraged, but it is not a requirement. Broadly relevant technologies should in fact find test-beds in a variety of biomedical contexts. It is the quality and potential impact of these test-beds, rather than their thematic consistency that should drive their selection. In any case, care should be taken to show that the technology is biomedically relevant, the Driving Biological Projects and other collaborations will provide appropriate drivers for technology development, and the technologies will be integrated appropriately to form a coherent analytical system. Investigators should propose to tackle a problem that is both technically challenging and relevant to biomedical research. These projects should be structured to achieve significant progress in a 5 year timeframe.

Through collaborations, infrastructure development, training, and dissemination, TCNPs will be expected to have a broad-based, significant impact on a variety of biological problems. However, the most important deliverables will be the state-of-the-art technology, reagents and methods for proteomics research developed in Core 1.  In the context of this solicitation, technology development should be interpreted broadly to encompass all aspects from proof of principle of an innovative idea through development of practical instruments and systems. It is anticipated that as innovative technology is developed, to the extent possible, it will be optimized and brought to bear in application to challenging biomedical research problems. It will be considered appropriate to balance evolutionary technology development, the refinement and optimization of current technologies, with the more challenging development of revolutionary new approaches. 

In core 2, an applicant will propose a minimum of 4 pilot projects that address cutting edge biological questions within the thematic biological research topic of the Center. The projects will involve collaborations with biomedical researchers who would use technologies under development in the TCNP. The defining characteristic of Driving Biological Projects is that they should provide both a driver and a test-bed for the technological research and development carried out in core 1. They should address hard problems whose solution requires the technology being developed in the center. Interactions with these projects should serve to ensure that the research carried out in core 1 has direct relevance to biomedical research. That linkage must be made explicit in the description of each DBP.

These projects will be at different degrees of maturity. Some may require funding through the center, but others will not. For a project to be funded through the center, it should be a pilot project anticipated to lead to independent funding within 1 to 3 years. It is anticipated that some DBPs will begin during the first year, while others may be phased in over the lifetime of the award. They may be very brief (weeks) with small budgets (less than $10,000) or more complex (up to three years at $75,000 per year direct costs).

Plans must be presented to select additional DBPs in an ongoing manner as these are completed. It is expected that the number of DBPs will increase significantly over the life of the center, with the majority of collaborating investigators not receiving direct funding through the center. In most cases the center should support only those aspects of the research conducted within the TCNP.

Whether or not the projects are funded through the center, they should be described in the proposal under Core 2. If separate funding is already available, that should be made explicit, including the grant number if it is NIH funding. It is anticipated that independently funded biological projects, either pre-existing or mature DBPs, will form strong continuing interactions with the TCNPs.  It is expected that a majority of the DBPs in core 2 will come from outside the institution(s) that make up the Center. It is expected that the Center will have a national scope and impact.  It is anticipated that technologies proposed in applications will be at different stages of maturity, both among and between centers. It therefore may be appropriate that the proposed function of a DBP collaboration be limited at least initially to helping the center appropriately define a specific problem.

The new tools, reagents, and methods that are being developed are likely to require substantial infrastructure to implement them. Core 3 will provide that infrastructure. This infrastructure will be used to develop appropriate components and to provide the biomedical community with access to these components. It is appropriate to request hardware, software, and associated personnel in this core.  It is expected that demand may outstrip available resources. Specific plans should be presented for the following: ongoing selection and prioritization of new DBPs, other biological collaborative projects, and routine service work.

The NIH’s long-term goals in proteomics recognize the need to develop a new generation of multi-disciplinary scientists. The twofold training mission of a TCNP should be described in core 4: Each center should develop mechanisms for ensuring that graduate students and postdoctoral fellows receive broad, relevant training beyond the specific contributions they make to the infrastructure and research projects of the center. In addition, there should be plans for workshops, training courses, or other mechanisms to train the larger biomedical research community about the new tools and techniques that the TCNP is developing.

The focus of core 5 is to disseminate new discoveries, reagents, methods and technology to the biomedical community and to participate in an effort to develop standards for data sharing and integration.  Publications and a genuinely useful web site are excellent ways to broadcast some of the discoveries of the TCNP, but those routes may not be sufficient to inform biomedical investigators who require guidance in pursuing solutions to their questions. Innovative plans to disseminate discoveries to the biomedical community should be presented in core 5. It is also appropriate to discuss how hardware, analytical methods, or software will be made available to the community in this core and to justify possible restrictions. Finally, where appropriate, plans to make data sets and databases available on a continuing basis should be presented. The development of data standards and ontologies is extremely important for sharing and communicating data and information. It is expected that multiple TCNPs will participate actively in an effort to develop standards for data sharing and integration.

It is essential to provide appropriate project leadership and management for these large centers. In core 6 the investigator should describe management plans. Investigators are strongly encouraged to consider proposing a project manager for the TCNP. The investigators should undertake a strategic planning process and document an action plan.  Elements of an action plan include determining which cores will be established; establishing overall policies and procedures for management of cores and Center resources. In addition, outcome measurements should be determined and include how progress on action plans will be measured. In addition to a project manager, it is expected that each TCNP will assemble an External Advisory Board, selected by the center investigators AFTER awards are made. This committee will meet at least annually to review progress and offer advice to the center investigators. NIH Program Directors and Project Scientists will attend these meetings. The application should NOT include the names of potential members of a proposed center’s External Advisory Board.

Multiple institutes and centers at NIH continue to support programs to develop centers in proteomics. Recipients of those awards or contracts are welcome to apply for the U54 centers in this announcement. It is anticipated that in those cases, the U54 application must be responsive to this FOA, but may be tailored to complement the center’s existing mission while addressing the additional unique features of this program. No preference will be given either to recipients or non-recipients of previous proteomics center awards or contracts. This announcement should not be viewed as a vehicle for continued support of conventional proteomics technology development begun under other programs.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U54 award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

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

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

This FOA represents a continuation through 2013 of a program begun in FY2004. The program will not be renewed in its present form.

2. Funds Available

The estimated amount of funds available for support of 3-6 projects awarded as a result of this announcement is $12M for fiscal year 2009. Future year amounts will depend on annual appropriations.

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

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to the FOA.

Renewal applications of U54 awards issued under RFA-RM-04-005 or RFA-RM-04-019 will be permitted for this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct.

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Supplementary Instructions

It is recognized that the proposals in response to this FOA will be longer and more complex than many other NIH proposals. In order to ensure effective review, the Research plan should be divided into sections according to the cores defined below, and separate page limits should be observed for each section as described below. See the FOA sections on RESEARCH OBJECTIVES and SPECIAL REQUIREMENTS for additional application instructions for the cores.

The U54 center will be required to have six cores: (1) conducting research in technology development, (2) establishing Driving Biological Projects (DBP) to allow biomedical researchers to interact with and drive research in the TCNP, (3) providing infrastructure to biomedical researchers (hardware, software, and personnel as appropriate), (4) enhancing the training for biomedical researchers in appropriate tools and techniques, (5) disseminating newly developed tools and techniques to the broader biomedical research community, and (6) providing formal project leadership and management to ensure that these large national programs achieve their goals within the 5 to 10 year funding lifetime of the center.

Form Pages 4-5: The budget should be completed as described in the instruction sheet for Application for a Public Health Service Grant (Form PHS 398). Applications should contain an overall detailed budget, and projections for the entire project period of five years.  Budgets containing the same level of detail, also on form page 4, should be supplied for the following: Each of the technology development projects contained in Core 1, each of the driving biological projects in Core 2, and if not redundant with these two categories, for each consortium or subcontract agreement. Separate budgets should also be included for each of Cores 3, 4, 5, and 6.  The budget pages should be presented together. The budget justification should be organized by budget section.  The budget justification beginning on PHS Form Page 5 should include a detailed justification for key personnel. As part of the justification, the percent effort that all staff are spending on each core should be specified. For example, a particular postdoctoral fellow might spend 75% effort on core 1 and 25% effort on one of the DBPs in core 2.  A detailed justification should also be supplied for equipment over $25,000 requested for the TCNP. Details of the physical location for this equipment should be provided. Existing equipment should also be described.

A detailed budget justification should also be provided for contractual or consortium arrangements. Use continuation pages as needed.

Biographical sketches must be included together in one section, according to the PHS 398 instructions, rather than within the research plans of individual projects. They should be organized for easy reference.

Section 5, Research Plan: We request that all applicants use the following format for the Research Plan:

A. Program Introduction: A general narrative describing the goals, overall significance, theme, general research plan, and preliminary studies. Describe the interrelation and synergy between different components and cores. Describe the quality control and oversight. We recommend the use of a diagram to describe the plan for communication.  This section may not exceed 10 pages. See page limits described below.

B. Research Design and Methods: Each of the six cores should be described. Use separate headings for each of these cores. It is recommended that each project in cores 1 and 2 be broken into four sections: Specific Aims; Background and Significance; Preliminary Studies, or Progress Report for Renewal Applications; Project Design and Methods. The content of Cores 3, 4, 5, and 6 may be structured however the applicant deems appropriate, but each core must be presented separately.  Each project within Core 1 may not exceed 25 pages. Each project within Core 2 may not exceed 10 pages. Core 3 may not exceed 25 pages. Cores 4, 5, and 6 may each not exceed 10 pages.

The remaining sections follow in order according to PHS 398 guidelines, viz, Human Subjects Research, Vertebrate Animals, etc.

Applications Involving Federal Agencies

The requests from federal agencies, including the NIH intramural program, will not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).

In general, the budget requests will be limited to the incremental costs required for carrying out the proposed work.  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. While support for extramural collaborators may be requested in a separate grant application, funds can be requested for services by an external investigator or contractor as a subcontract/consortium including the applicable indirect (F&A costs) of the contractor/collaborating institution.

Justification must be provided for all requested support and for the Federal employees who will be committed to the project although no funds are requested in the application.

Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

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: September 28, 2008
Application Receipt Date: October 28, 2008
Peer Review Date(s): February – March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Douglas M. Sheeley, Sc.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Telephone: (301) 594-9762
FAX: 301-480-3659
Email: sheeleyd@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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).

3.C. Application Processing

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

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

Renewal applications of U54 awards issued under RFA-RM-04-005 or RFA-RM-04-019 will be permitted for this FOA. Applications for continued funding of existing centers under this program should be submitted as renewals. Appropriate introduction and progress report sections should be included in the application, describing the progress during the first project period and how this relates to the current application.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

Funds for support of travel and other expenses associated with annual meetings of the center’s External Advisory Board are to be included in the application under Consultant Costs. These funds may not be rebudgeted for other uses without prior approval from the TCNP Program Director.

Funds designated for Driving Biological Projects (Core 2) may not be rebudgeted out of that Core without prior approval from the TCNP Program Director.

6. Other Submission Requirements and Information

Special Requirements

Responsiveness

Applicants are encouraged to contact program staff well in advance of the letter of intent submission date, in order to discuss the proposed research program, budget, organization of the center, and its potential biomedical impact. These contacts help to assure that applicants have a clear understanding of current program policies and priorities, especially with respect to any special situations, such as the inclusion of consortia, subcontracts, etc. It will also allow staff to assess responsiveness to this FOA and provide appropriate guidance as needed. Programmatic guidance from NIH staff does not imply pre-review or approval of the science proposed.

Annual Program Meeting

Principal investigators and key personnel as appropriate are expected to participate in an annual meeting in the Washington, DC area. Funds for travel to the meeting should be requested in the budget.  The annual progress report for the U54 award will use the standard 2590 form. In addition, to the basic information in that form, the annual progress report for the U54 centers will be more involved. Additional information in the progress report will include both the progress made in the center as well as the relationship between the center and the individual investigator awards. Details of the U54 progress report are spelled out in the notice of grant award and in the Terms and Conditions section of this FOA. Applications for U54 centers should contain appropriate personnel to collect the needed information and to prepare this progress report.

Site Visits

Because of the complexity of the TCNP, program staff from NIH will conduct annual administrative site visits. TCNP centers should be prepared for annual visits and should budget appropriately (including travel for collaborators and other necessary costs).

Project Managers

The complexity of these centers necessitates a project manager. Centers should budget appropriately for these managers. One of the review criteria for these centers will be the qualifications of these project managers as well as whether the institution has an appropriate career pathway for these individuals. Because of their important role, it is recommended that the project manager be listed as one of the key personnel.

Organizational Plan

A principle underlying this program is that substantial benefits in technology development and biological problem solving will accrue through successful integration of the biological, analytical, and informatics domains of the center. The application should articulate a specific organizational plan in Core 6. This plan should describe anticipated interactions between key personnel in support of the overarching goals of the resource. It should also maximize synergy between the component technologies. Ultimately, a successful center will function as a coherent whole, rather than a collection of individual technological capabilities. In cases where geographically distributed collaboration is essential, the management plan should include provisions for teleconferencing or videoconferencing as appropriate. The applicant may include these provisions in the budget if appropriate.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

A. Program Introduction: This section may not exceed 10 pages.

B. Research Design and Methods: Each project within Core 1 may not exceed 25 pages. Each project within Core 2 may not exceed 10 pages. Core 3 may not exceed 25 pages. Cores 4, 5, and 6 each may not exceed 10 pages. These page limits are not additive. That is, unused pages from one section may not be used to exceed the stated page limits for another section.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

To address the joint interests of the government in the availability of, and access to, the results of publicly funded research, NIH expects applicants who respond to this FOA to propose detailed plans for sharing the research resources generated through the grant. It is expected that the resources to be shared include all materials developed in projects funded under the FOA. A reasonable time frame for release of materials should be specified in the application and will be considered during the review of the plan for sharing.  It is expected that the investigator’s data and biomaterials sharing plan will include the access to biomaterials and methods not currently available to the wider scientific community. In other words, plans for the development of resources for use by the biomedical community should have the appropriate timeliness and mileposts. For example software development should include plans and timeliness for alpha testing, beta testing, production release, interface development, bug reporting, integration with other codes, extension to multiple platforms, etc.

The scientific review group will evaluate the adequacy of the proposed plan for sharing and data access. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement, but will not affect the priority score.  The adequacy of the plan will be considered by NIH program staff and will be important in determining whether the grant shall be awarded.  The sharing plan approved by program staff, after negotiation with the applicant when necessary, will become part of the terms and conditions of the award. NIH program staff will evaluate the compliance with the sharing plan and scientific progress in the non-competing continuation of the grant award application.

Intellectual Property Rights

NIH is interested in ensuring that the research resources developed through this FOA become readily available to the research community.  With regard to patentable research results, such as genetically encoded reporters, cell lines, and vectors, the NIH expects applicants who respond to this FOA to develop a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community research resources produced in projects funded under this FOA. This is expected to include an elaboration of the applicant’s anticipated plans to generate, or not generate, patents and/or exclusive or non-exclusive licensing of biomaterials and other patentable subject matter created in projects funded under this FOA. This plan should be consistent with the applicant’s institution’s policies on intellectual property rights.  Applicants are reminded that funding recipients must not enter into any agreements with third parties that are inconsistent with the terms and conditions of their NIH award, if awarded, and must revise any agreements with third parties that are inconsistent with the terms and conditions of an NIH award to remain in compliance with such NIH award.  The majority of transfers to not-for-profit entities should be implemented under terms no more restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA). In particular, recipients are expected to use the Simple Letter Agreement (SLA) provided at http://grants.nih.gov/grants/intell-property_64FR72090.pdf, or another document with no more restrictive terms, to readily transfer unpatented tools developed with NIH funds to other recipients for use in NIH-funded projects. If the materials are patented or licensed to an exclusive provider, other arrangements may be used, but commercialization option rights, royalty reach-through, or product reach-through rights back to the provider are inappropriate. Similarly, when for-profit entities are seeking access to NIH-funded tools for internal use purposes, recipients should ensure that the tools are transferred with the fewest encumbrances possible. The Simple Letter Agreement may be expanded for use in transferring tools to for-profit entities, or simple internal use license agreements with execution or annual use fees may be appropriate.

Applicants also are reminded that the grantee institution is required to disclose each subject invention to NIH within two months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. The awarding institute reserves the right to monitor awardee activity in this area to ascertain if patents or patent applications on protocols, cell lines, vectors, or other patentable subject matter are adversely affecting the goals of this FOA.

As noted earlier, principles and guidelines for recipients of NIH research awards on obtaining and disseminating biomedical research resources can be found at http://grants.nih.gov/grants/intell-property_64FR72090.pdf.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

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 meritorious 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.  

This solicitation seeks to build a program in which a significant fraction of the effort is aimed at developing highly novel technologies that have the potential to provide quantitative information at high anatomic resolution (subcellular) and biologically relevant timescales needed to elucidate the function of molecular pathways and networks. This FOA therefore encourages the inclusion of the more challenging development of revolutionary new approaches as a component of the application. The degree of novelty and potential impact of these technologies will be important review criteria.

CORE 1. The criteria listed below will be applied to evaluation of each project within Core 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?

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?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the rating.

Is technology development proposed that would accelerate the progression of proteomics toward creation of dynamic functional models with temporal and spatial resolution? Are the technologies proposed integrated into a coherent overall strategy?

Each additional core of a TCNP has specific additional review criteria.

CORE 2: Do the investigators have appropriate plans to obtain support for the DBPs after their support from the TCNP has terminated? Does each DBP act as a test-bed and/or driver for the technology development proposed in Core 1?

CORES 1-2: Will the work proposed in these cores help establish an integrated approach to characterization of pathways and networks? Is the proposed work essential to establishing this approach? 

CORE 3: Are the infrastructure requests adequate to meet the demands that are likely to come from biomedical researchers? 

CORES 4 and 5: Will the proposed training and dissemination tools help create a new group of multi-disciplinary or interdisciplinary investigators? SOFTWARE AVAILABILITY: Does the plan for distributing the software reasonably allow wide and easy access? Are any fee structures appropriate?

CORE 6: Will the proposed management structure allow the TCNP to achieve its goals? Does the institution have an appropriate career path for the project manager? Is the mechanism to terminate old DBPs and choose new ones adequate? Will the plans to incorporate individual investigator awards work?

Reviewers will be instructed to consider all six components of the project as important, even if a particular component is only a relatively small part of the budget. For example, outreach and training, while not as costly as the core development of the technologies, are considered to be critically important for the TCNP to have the appropriate impact on biomedical research. 

NIH considers the following in evaluating Center grant applications:

2.A. Additional Review Criteria:

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

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 on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan 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.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of 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 NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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 an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

o Coordinating project activities scientifically and administratively at the awardee institution. The PI will have primary responsibility for defining the details for the projects within the guidelines of this FOA (RFA RM-08-021), and for performing all scientific activities. The PI will agree to accept the close coordination, cooperation, and participation of the NIH Science Officer(s), Technology Centers for Networks and Pathways Steering Committee in those aspects of scientific and technical management of the project as described below.

Specifically, the PI will:

Awardees will retain custody of and have primary rights to the data and software developed under these awards, 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.

This includes functioning as a peer with the PIs, facilitating the partnership relationship between NIH and the facilities funded under this FOA, helping to maintain the overall scientific balance in the program commensurate with new research and emerging research opportunities, and ensuring that the activities of the centers are consistent with the missions of the participating Institutes.

The role of NIH will be to facilitate and not to direct activities. It is anticipated that decisions will be reached by consensus of the PIs and that NIH staff will be given the opportunity to offer input to this process as members of Steering Committee.

Specifically, the NIH Project Scientist will:

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.

The Program Director(s) will:

2.A.3. Collaborative Responsibilities (optional)

Technology Centers for Networks and Pathways External Scientific Panel (ESP): The ESP will be responsible for reviewing and evaluating the progress of the TCNP centers in meeting their individual milestones and goals, and making recommendations about the progress and directions of the TCNP program and individual centers to the TCNP Project Team. The ESP will ensure coordination among TCNP projects funded under this FOA and evaluate their progress in relation to the evolving goals for trans-NIH initiatives on proteomics, molecular pathways and networks.

The ESP will use its knowledge of the activities of all of the participating facilities to ensure adequate investigation, communication and sharing, and to avoid redundant activities.  It will report to the NIH with respect to the coordination of all activities of the TCNP program. The ESP will make recommendations that will lead to exchanging research tools, research resources, adopting common policies on data sharing, creating compatible databases, and other activities that will make these facilities of maximal utility to the scientific community. 

The ESP will consist of a minimum of four scientists who are not affiliated with any of the TCNPs.  They will be appointed by NIH.  These scientists will be selected for their broad expertise in relevant topics.  The ESP will meet at least two times over the five years of the program.  A schedule for subsequent meetings will be prepared at the first meeting.

NIH will select one member to be the committee chair, after considering recommendations from ESP members.  The chair will schedule the first meeting and be responsible for developing meeting agendas and for chairing the meetings. Additional ESP members may be added by an action of the original members. The Steering Committee Chair and Science Officer(s) will attend the ESP as non-voting members and will act as representatives of the Steering Committee.  Other NIH staff and Steering Committee members may attend ESP meetings, when their expertise is required for specific discussions.

Technology Centers for Networks and Pathways Steering Committee: A committee that is the main governing board of all of the molecular pathways and network facilities funded under this FOA, and the committee through which the NIH interacts and collaborates with the facilities. Voting membership includes the NIH Project Scientists (one vote total), the PI of each awarded cooperative agreement, and three scientists with relevant expertise who are not affiliated with any of the funded projects. The NIH TCNP Program Director is an ex officio member of the committee.

NIH will interact and collaborate with the facilities principally through the Steering Committee. After appointment by NIH, the Project Scientists will schedule the first meeting and set the agenda, following which the Chair of the Steering Committee will rotate among the PIs and will be responsible for developing meeting agendas and chairing meetings. The Steering Committee will meet quarterly, but may use video or teleconferencing rather than face-to-face meetings, at the discretion of the committee members.  Additional Steering Committee members may be added by action of the committee. Other NIH staff may attend Steering Committee meetings, when their expertise is required for specific discussions.

The Steering Committee will coordinate the activities of the centers and the exchange of information and biomaterials with the wider scientific community.  The committee will discuss scientific progress and make recommendations regarding how the centers achieve their scientific goals. TCNP Advisory Panel recommendations will be addressed by the Steering Committee.

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

2.A.4. 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The progress of the TNCPs will be reviewed annually by the NIH Program Director(s) and TCNP Project Team to assure that satisfactory progress is being made in achieving the project objectives. During the first year of funding, and during subsequent years if deemed necessary by the Program Director, reviews may be more frequent. Should problems arise in the conduct of the study, the NIH Program Director may require that the awardee submit quarterly reports on progress and fiscal matters.  The progress report will have two components. The first will be the standard NIH progress report (Form 2590). The second will be a more specialized report that will go to the NIH Project Scientist(s) and the NIH Program Director. This specialized report should be included as an attachment to the standard progress report. The contents or the report may be changed according to programmatic needs, based on discussion between NIH program officials, the PI and the Steering Committee.  The awardees’ yearly milestones will be provided to the Steering Committee.  It is expected that the milestones should be adjusted annually at the award anniversary dates, both to incorporate a group’s scientific accomplishments and progress in the field in general, as well as to reflect Steering Committee recommendations. Following the evaluation of milestones, NIH program staff may recommend augmenting any project or reducing or withholding funds for any project that substantially fails to meet its milestones or to remain state-of-the-art.

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Douglas M. Sheeley, Sc.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Telephone: (301) 594-9762
FAX: 301-480-3659
Email: sheeleyd@mail.nih.gov

2. Peer Review Contacts:

George Chacko, Ph.D.
Chief, Bioengineering Sciences and Technologies
Division of Molecular and Cellular Mechanisms
Center for Scientific Review, Room 5170
National Institute of Health
6701 Rockledge Drive  
Bethesda, MD 20892-7844
Telephone: (301) 435-1245
Fax: (301) 480-1988    
E-mail: chackoge@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Claudette Grubelich
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd, Room 1050
Bethesda, MD 20892-4874
Telephone: (301) 435-0835
FAX: (301) 480-3777
Email: grubelic@mail.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.

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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.

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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NIH Funding Opportunities and Notices


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