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 Request for Applications (RFA) is developed as an NIH Roadmap initiative (http://nihroadmap.nih.gov). All NIH institutes and centers (ICs) participate in Roadmap initiatives. This RFA will be administered by the National Human Genome Research Institute (NHGRI) (http://www.genome.gov) on behalf of NIH.

Title: Exploratory Centers for Cheminformatics Research

Announcement Type
New

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

Catalog of Federal Domestic Assistance Number(s)
93.172

Key Dates
Release Date: December 13, 2004
Letters Of Intent Receipt Date(s): February 17, 2005
Application Receipt Dates(s): March 10, 2005
Peer Review Date(s): June – July, 2005
Council Review Date(s): August - September, 2005
Earliest Anticipated Start Date: September 30, 2005
Expiration Date: March 11, 2005

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The National Institutes of Health under the Roadmap initiative invites applications for Exploratory Centers (P20) for Cheminformatics Research that will allow teams of investigators to identify areas of research within the broad areas of computational and theoretical chemistry and to establish and develop collaborative arrangements for the subsequent application for Cheminformatics Research Center (P50) grants. This initial funding will provide for identification of critical cheminformatics needs of the biomedical research community and the formulation of collaborative strategies to address those needs, culminating in the generation of preliminary data to support the P50 proposal. This initial funding will also allow awardees to become familiar with the operation and interactions among the various components of the NIH Molecular Libraries Initiative, and how Cheminformatics Research Centers could contribute to this effort. Only applications for P20 planning grants will be accepted for this Request for Applications (RFA). An RFA for follow-on NIH Cheminformatics Research Centers (P50) is anticipated in approximately two years. The NIH intends to commit $4 million dollars in FY 2005 to fund approximately 10 new grants in response to this RFA.  Eligible organizations include domestic public or private institutions, units of State and local governments, and eligible agencies of the Federal government.  Foreign institutions are not eligible to apply, but can participate by collaboration or subcontract.  There is no limit on the number of applications from an institution or individual.  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 encouraged to apply for NIH programs. Depending on response to this RFA and available funds, an additional 2-4 grants may be funded in FY 2006. Applications must be prepared using the PHS 398 application forms, available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Additional instructions, found in Section IV below, should be followed for this RFA. Telecommunications for the hearing impaired is available at: TTY 301-451-0088.

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
    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
      A. Receipt and 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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative 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

The NIH Roadmap is a series of initiatives designed to pursue major opportunities in biomedical research and gaps in current knowledge that cannot be addressed by any single NIH Institute or Center on its own, but that must be addressed by the agency as a whole. The goal is to enable the rapid transformation of new scientific knowledge into tangible benefits for public health (http://nihroadmap.nih.gov/).

The Molecular Libraries and Imaging Initiative is a component of the “New Pathways to Discovery” theme of the Roadmap. The goal of this initiative is to augment the “toolbox” for understanding the functionally interconnected networks of molecules that comprise cells and tissues, their interactions and regulation, and the combinations of molecular events that maintain health and lead to disease. The last decade has witnessed major breakthroughs in the identification of genes, gene products, metabolic pathways, and signaling pathways, as well as progress in miniaturization and robotics, enabling the development of high-throughput, highly specific, mechanism-based biological assays. The new assays have, in turn, enabled the discovery of small molecules with powerful physiological effects. While there are tens of thousands of gene products that might play a role in disorders of human health, the entire arsenal of drugs currently aims at only a few hundred of these as targets for therapeutic intervention. The Molecular Libraries Initiative represents a concerted, multi-faceted effort to address this discrepancy by developing and discovering small molecules that hold promise as research tools to probe cellular physiology and pathophysiology. While high-throughput screening (HTS) of small-molecule libraries is widespread in the pharmaceutical industry, the academic community has not for the most part availed itself of the considerable potential of small molecule technologies to improve the understanding of biology. This is because most academic scientists have limited access to automated screening facilities, to libraries of structurally diverse compounds, and to robust informatics tools.

The NIH Roadmap Molecular Libraries Initiative (MLI) is made up of a series of integrated research programs with the goal of making small molecule screening and screening data more widely available to the research community (http://nihroadmap.nih.gov/molecularlibraries/index.asp). The three components of the MLI are:

a. The Molecular Libraries Screening Center Network (MLSCN), a network of small molecule screening centers accessing a central compound repository (see http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-017.html)

b. Cheminformatics, which is made up of PubChem, a public sector database of chemical structures and bioassay results (http://pubchem.ncbi.nlm.nih.gov) and activities solicited by this RFA

c. Technology development in four critical areas

1. Chemical diversity: pilot-scale libraries for investigation of novel chemical diversity space; novel methods for natural product chemistry
2. Development of assays (see http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-012.html)
3. Novel instrumentation and detection technologies for high throughput screening (see http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-020.html)
4. Datasets and algorithms for better prediction of absorption, distribution, metabolism, excretion, and toxicity properties of small molecules

The MLI differs from HTS efforts in private industry in several ways. First, the NIH's interest goes beyond the identification of compounds with potential therapeutic properties. The range of the effort will involve screening a greater diversity of small molecules in assays that will encompass a broader range of novel biological targets and activities. The MLI will result in the identification of a large number of compounds for use as probes to study cellular processes in health and disease. Second, the biological screening data, assay protocols, and chemical structures for compounds tested in the Molecular Libraries Screening Center Network (see below) will be publicly available for data mining via the PubChem database. Third, the MLI does not include plans to engage in the much more extensive aspects of drug development. It is anticipated that the initiative will complement private sector drug development efforts by contributing to the identification and validation of novel drug targets, particularly for rare or marginalized disorders.

Objectives of the Project

This RFA solicits applications for Exploratory Centers for Cheminformatics Research (ECCR). An ECCR should be viewed as a precursor to a Cheminformatics Research Center (CRC), which will be a full-scale research center for the development of computational algorithms, software tools, theoretical insights, and data-rich resources applicable to chemical diversity and high-throughput screening. As such, an ECCR grant will provide the means for developing the collaborations as well as the synergistic scientific approaches that will be required for a successful CRC grant application.

The motivation behind this two-phase approach (ECCR, followed by CRC) is that (a) collaborative, team-based approaches are likely to lead to intellectual cross-fertilization and the generation of insights that otherwise would not be achievable; (b) opportunities for collaboration have been limited in this field of science; (c) it may take time and effort to develop both the compelling scientific themes and objectives as well as a suitable team that will be required to assemble a successful CRC application; (d) it may take time and effort to develop the infrastructure to allow collaborative development and integration of software tools; and (e) preliminary results obtained during the ECCR phase are likely to strengthen a subsequent CRC application and may even lead to useful insights and/or tools. (It is anticipated that a CRC competition will be announced in a separate RFA in the summer or fall of 2006.) This initial funding will also allow awardees to become familiar with and help to refine the operational and technical requirements for connecting to other parts of the MLI. Key will be the linkage to the PubChem database at NCBI/NLM, and with other awardees of this RFA, some of whom are likely to be part of the ultimate cooperative CRC effort.

Several aspects of the MLI will require, or be complemented by, computational approaches. Among these are a scientific and theoretical understanding of biologically relevant chemical diversity, computational tools to explore chemical diversity and screening space, and applications of those tools to the production of novel libraries and the analysis of large screening datasets. The screening centers of the MLSCN will screen hundreds of thousands of compounds on tens to hundreds of assays per year, resulting in a massive amount of data that will be deposited in PubChem. Assays screened will include both single-parameter (e.g., biochemical or reporter) and multi-parameter phenotypic (a.k.a. “high content”) assays of cells or model organisms. Primary data from such screens will be available in public databases for computational analysis, and for model-building to determine the optimal way to analyze and compare results from different assay formats.

Support provided under this RFA is meant to stimulate the establishment of multi-investigator research centers whose mission will be to develop state-of-the-art methodologies for computational exploration of chemical diversity space and the relationship to biological activities. The Cheminformatics Research Centers (CRCs) will feature collaborations and team approaches that otherwise would not be established, including individuals from subdisciplines such as cheminformatics, theoretical chemistry, and computer science, who will take complementary approaches to fundamental and applied studies related to chemical diversity. The ultimate goal is to develop insights and computational tools that will further the goals of the NIH MLI, namely, to develop molecular tools for interrogating complex biological systems.

Examples of topics that would be appropriate for investigation under this RFA (and the future RFA for the establishment of the CRCs) are the design, operation, and dissemination of virtual chemical library enumeration and screening algorithms, and tools for user-defined m ultidimensional analysis of high throughput screening data. A separate objective of this RFA is to support the computational and theoretical characterization of chemical diversity. There are many parameters that can be used to classify small molecules, but none of these has shown consistent correlation with activities in biological systems. Thus, an example of an appropriate topic is analysis of the dimensionality (-ies) of chemical diversity space that are the most critical for designing an optimal compound collection for screening of biological targets. These broad examples serve only to illustrate the intent of the RFA, and in no way describe the full range of possible concepts responsive to the RFA.

Approaches Being Sought to Achieve the Objectives

The CRCs will be collaborative, both within the centers, and with other components of the MLI. Investigators of the Centers will participate in the development of strategies to coordinate their research with other components of the MLI. Collaboration with the MLSCN will facilitate experimental testing of the new virtual screening algorithms, and collaboration with investigators being funded under the ML Chemical Diversity initiative for making pilot-scale libaries will allow the translation of new computational combinatorial library enumeration tools into physically synthesized libraries. Investigators funded under this RFA will contribute to a networked national effort to develop broadly applicable informatics resources (e.g., software tools for data analysis) for probing the relationships between particular small molecules and specific biological processes. These informatics resources and tools will be used by the research community at-large, and will interoperate with other facets of the MLI. Thus, generation of software tools that are easily distributed and make use of public archives such as PubChem is as important as the development of the analysis tools themselves. Informatics tools developed by the CRCs will need to be robust, generalizable, scalable, well documented and developed using best practices (e.g., understanding data use and flow, needs of users, etc.). Informatics tools and resources developed by the CRCs (as well as the ECCRs) will be publicly accessible, as will the source code, to allow the fullest possible utilization of the resources by the scientific community.

An ECCR must be an integrated, coordinated project, with interdependent subprojects that are described fully and justified in the grant application.  Collaborations and consortia are strongly encouraged, and the interactive nature of the proposed research is a key factor that will be evaluated in peer review.  The benefits to be achieved through the establishment of novel collaborations, as opposed to working independently, should be described fully.  It is the applicant's responsibility to make a strong case that the proposed ECCR is more than a collection of independent or semi-independent research projects. The applicant should identify clearly in the abstract, and more fully in the research plan, the new capabilities that are proposed to be developed, or what specific questions are to be studied, as a result of the establishment of the Center.

An ECCR will minimally comprise three independent investigators who will work on one or more research and/or tool development projects. Projects currently funded by NIH may complement individual components of an ECCR application, but research from a current award cannot be duplicated.  The effectiveness of the proposed Center structure will be a criterion of the peer review evaluation prior to an award. Participants in a Center may come from the same or different departments of a single academic institution or from different institutions, and they may come from industry as well as academia.  However, industry participants must be willing to abide by the ECCR guidelines, including data sharing, software accessibility, and handling of intellectual property. Centers that involve participants from more than one physical site are welcome under this solicitation.  If any of the components is physically separated from the others (e.g., different departments or institutions), the applicant should describe how interactions will be facilitated.  If the team includes investigators from more than one institution, a "letter of intent to collaborate with the applicant organization" signed by the appropriate institutional official from each participating organization must be included in the application. Projects of the anticipated degree of complexity, both scientific and managerial, will require a substantial investment of the PI's effort.  The PI will be required to devote sufficient effort to ensure successful leadership and implementation of the goals of the Center. 

This RFA invites applications for ECCR grants under the NIH P20 exploratory grant mechanism. This mechanism is being utilized to provide investigators with resources to collect preliminary data, enhance collaborative networks by strengthening and establishing new multi-investigator relationships, demonstrate effective collaborations, explore organizational concepts, and refine and fully develop the vision of the proposed P50 CRC project. A P20 exploratory grant will not be required as a precursor to a P50 Center application, nor does the award of an exploratory grant obligate NIH to fund a subsequent P50 Center grant. In addition to scientific and technical goals, applications for the P20 Exploratory Centers should describe:

Applicants should describe collaborative research projects as well as mechanisms for promoting scientific interactions among the participants.  Plans must be presented for effective team communication and coordination of effort that covers the development, implementation, and conduct of all aspects of the research program.  The degree of synergy among the participating research groups and the benefits that may be expected to result from these interactions will be major criteria in peer review and in NIH funding decisions.  It is essential to justify the proposed Center in terms of the "value added" beyond what would be expected from a set of independent R01-style projects.

Project Oversight

As part of the larger Molecular Libraries and Imaging Roadmap Initiative, projects that are funded under this RFA are subject to oversight and evaluation of each aspect of the effort.

THE MOLECULAR LIBRARIES CHEMINFORMATICS PROJECT TEAM. The Project Team will be the operational governing body for the initiative and will include NIH staff from various Institutes and Centers who are actively involved in the management and implementation of this Roadmap initiative. The Project Team will report to the Molecular Libraries and Imaging Implementation Group.

THE MOLECULAR LIBRARIES AND IMAGING IMPLEMENTATION GROUP (MLIIG). The MLIIG comprises the Directors of NHGRI, NIMH, and NIBIB and the NIH staff who coordinate the major components of the Molecular Libraries and Imaging Roadmap Initiative. The MLIIG will provide overall guidance and assist grantees in establishing connections to other components of the ML Initiative.

In addition to these oversight committees, grantees under this RFA will interact with the THE MOLECULAR LIBRARIES SCREENING CENTER NETWORK (MLSCN). The MLSCN is a national resource providing innovative high throughput molecular screening (HTS) for the identification of small organic molecules that are active in biological assays. In addition, the MLSCN will use synthetic chemistry to improve the utility of these molecules as probes for in vitro, and potentially in vivo, studies of normal and abnormal physiology of cells, organs, and/or organisms.

MLSCN COMPOUND ACQUISITION WORKING GROUP. This group will oversee the operation of the Repository and the management of the NIH Small-Molecule Collection. It also will evaluate proposals for the acquisition of small molecules from public and private sources for the Repository.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH P20 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

The participating IC(s) National Human Genome Research Institute, on behalf of the NIH Roadmap, intends to commit approximately $4 million dollars in FY 2005 to fund approximately 10 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 2 years and a budget for direct costs up to $250,000 dollars 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

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:

Foreign institutions are ineligible to apply, as per the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600262).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 programs.

2. Cost Sharing or Matching

Cost sharing 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

Relevance to the goals of the RFA described under Section I, Research Objectives, will be considered in accepting applications for review. Applicants may submit more than one application under this announcement.

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 301-451-0088.

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

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

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): February 17, 2005
Application Receipt Dates(s): March 10, 2005
Peer Review Date(s): June – July, 2005
Council Review Date(s): August - September, 2005
Earliest Anticipated Start Date: September 30, 2005

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:

Bradley A. Ozenberger, PhD
National Institutes of Health
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD 20892-9305
(express/courier services should be directed to Rockville, MD 20852)
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: bozenberger@mail.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)

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

Ken Nakamura, PhD
National Institutes of Health
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD 20892-9306
(express/courier services should be directed to Rockville, MD 20852)
Telephone: (301) 496-7531
FAX: (301) 435-1580
Email: nakamurk@exchange.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 National Human Genome Research Institute and the NIH Roadmap Molecular Libraries Cheminformatics Project Team. 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.

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

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

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.

Plan for Sharing Software

A software dissemination plan, with appropriate timelines, must be included in the application. There is no prescribed single license for software produced in this project. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

The application MUST include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including subcontractors), to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application. These letters must be clear expressions of commitment. A separate letter should be sent by each participating organization including each subcontractor. Lack of such letters will result in withdrawing the application as non-responsive.

Additionally, peer reviewers and program staff will evaluate the adequacy of dissemination plans prior to award. Please note that institutional sign-off on the grant application signifies that all relevant components of the institution, including the technology transfer office, have reviewed and approved the document.

The initial review group will comment on the appropriateness of the proposed plan for data and materials dissemination. Program staff and advisors will also consider the adequacy of the dissemination plan as one of the criteria for award. The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the National Human Genome Research Institute and the ML Cheminformatics Project Team. Incomplete applications will not be reviewed.

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 National Human Genome Research Institute 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? Is there an important biological question being addressed by the computational chemistry approaches? Will the proposed approach afford insights into novel aspects of chemical diversity and/or structure/function relationships? Will the tools and techniques developed be useful to the research community and integrate with the other ECCR centers and the other ML initiatives?

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? How likely are the proposed strategies to result in the development of novel understandings of the theoretical or computational aspects of chemical diversity space, or tools to explore relationships to biological activity? Are the plans for developing a collaborative group approach adequate? What is the likelihood that the proposed exploratory grant will culminate in the ability to submit a high quality CRC P50 grant application through, for example, the development of on-going collaborations and generation of relevant preliminary data, and crystallization of research approaches.

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:

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.

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. Sharing Research Data

1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may 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 funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2. 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.

Software Sharing Plan: Reviewers will be asked to assess the adequacy of milestones for software dissemination; whether the plan for sharing and distributing the software allows wide and easy access; the appropriateness of any fee structures; and the plans and methods for ensuring interoperability of data and software.

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.

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.

The NGA will be sent by e-mail to the authorized business official at the grantee institution.

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
Not applicable.

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.

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:

Bradley A. Ozenberger, PhD
National Institutes of Health
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: bozenberger@mail.nih.gov

2. Peer Review Contacts:

Ken Nakamura, PhD
National Institutes of Health
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Telephone: (301) 496-7531
FAX: (301) 435-1580
Email: nakamurk@exchange.nih.gov

3. Financial or Grants Management Contacts:

Cheryl Chick
National Human Genome Research Institute
Grants Management Branch
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Telephone: (301) 435-7858
FAX: (301) 402-1951
Email: ChickC@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).

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.

Public 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 public 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.

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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