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 announcement is developed as an NIH Roadmap Initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate in roadmap initiatives. This announcement will be administered by the National Human Genome Research Institute on behalf of the NIH.

Title:  Preapplication for Cheminformatics Research Centers (X02)

Announcement Type
New

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-353

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: April 13, 2007
Opening Date:  May 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 7, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  June 28, 2007
Peer Review Date(s): Sept-Oct, 2007 
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): Not Applicable
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: June 22, 2007

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
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, now part of the NIH Office of Portfolio Analysis and Strategic Initiatives, 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 Roadmap Program (MLP) is an integrated set of initiatives aimed at developing and using selective and potent chemical probes for basic research, with three main components: (1) Data Production, (2) Data dissemination, and (3) Technology Development. The MLP was proposed to introduce high-throughput screening approaches to small molecule discovery, formerly limited to the pharmaceutical research industry, into the public sector. Advances in many areas of technology and the completion of the reference human genome now provide unprecedented opportunity to bring the art and science of molecular library screening to bear on basic biomedical research.  Furthermore, new probes can provide starting points for drug development, particularly for rare and neglected diseases.

The MLP is made up of the following major components: (1) access to a library of compounds (Molecular Libraries Small Molecule Repository); (2) access to bioassays provided by the larger research community; (3) support for the development of breakthrough instrumentation technologies; (4) access to a network of screening and chemical probe generation centers (MLPCN) where assays are screened and probe development is undertaken; (5) Pubchem, the primary portal through which the screening results of the MLPCN are made public and (6) the Cheminformatics Research Centers (CRCs) with multiple roles focused on high-level data analysis and dissemination with a focus on developing new understanding of the cellular processes (genes and pathways). The RFAs (past and current) for these components can be found at http://nihroadmap.nih.gov/molecularlibraries/.

The CRCs are the focus of this announcement. As part of the MLP, a program to support exploratory centers for cheminformatics research was initiated in FY2005 (http://grants1.nih.gov/grants/guide/rfa-files/RFA-RM-05-012.html), and six planning awards were funded (http://nihroadmap.nih.gov/molecularlibraries/fundedresearch.asp). This announcement is the next step in the program for creating full Cheminformatics Research Centers. Participation in the CRC phase of the program is not limited to the funded exploratory centers; any research team is allowed to apply.

The pre-application (X02) will be used to identify the applicants who will be invited to respond to the CRC FOA with a full application. It is expected that the CRC FOA will be published in the NIH Guide in a few weeks time. The review criteria for this pre-application will include scientific, software engineering, and training criteria along with relevance to overall MLP program priorities. Following the preapplication review, the NIH Roadmap Molecular Libraries Implementation Group (http://nihroadmap.nih.gov/molecularlibraries/members.asp) will invite applications for a full center application. Only applicants who have submitted a pre-application will be allowed to compete for a full center.

Objectives of the Project

One of the key goals of the MLP is to release all data to the public. These constitute the first such comprehensive molecular probe data sets available without restrictions to the scientific community.  As such, they make possible an extraordinary opportunity for exploring the interactions of small molecules with cells (genes and pathways) and eventually to contribute towards drug discovery efforts. Developing such an understanding of cellular systems, along with enabling software tools (in the public domain) for academic scientists to further probe/drug discovery efforts is the overall objective of the Cheminformatics Research Centers. The CRC initiative is a research program with responsibilities for providing both scientific and software engineering infrastructure. Both these responsibilities are critical as novel computational approaches will need appropriate software engineering infrastructure to enable dissemination and use by the wider scientific community. This wider scientific community includes other computational scientists (e.g., other cheminformatics and bioinformatics scientists) as well as bench chemists and biologists.

The CRCs will be ‘centers of excellence’ that will provide infrastructure and technologies to address the outstanding needs of cheminformaticians and bench scientists involved in chemical biology, high-throughput screening, and probe discovery both within and outside of the MLP. The CRCs also will be centers for training the cheminformaticians who will be needed for the community to fully utilize the enormous amounts of screening data being produced by the MLP. CRCs will be responsible for building informatics tools that will enable understanding of the general principles by which small molecules modulate cellular function.

The following four broad themes incorporate the overall Cheminformatics goals of the MLP:

1)     Deriving new hypotheses about gene, pathway, and cell functions based on meta-analyses of data from the hundreds of assays performed by the MLPCN.

2)     Enabling infrastructure and tools that (can preferably be downloaded and used) increase the efficiencies within academic and other public sector hit-to-probe (or broader drug discovery) efforts. Specific and different tools as well as graphical user interfaces might be necessary for expert cheminformaticians and bench biologist or chemist.

3)     Benchmarking and standardization will be necessary at multiple levels (chemical structure, assays, algorithms) to enable detailed understanding of the strengths and weaknesses of these infrastructural and algorithmic developments, especially in comparison to currently available methods.

4)     Education and training of the next generation of cheminformaticians.

The following examples provide more details on these objectives.

A.)  Benchmark and share novel modeling (2D, 3D, docking, SAR etc.) and virtual screening algorithms with the community. These efforts will also provide novel publicly accessible methods to look across multiple biological assays to reveal an understanding of the general principles of protein-small molecule interactions (meta-analysis).

B.)  Building graphical user interfaces for screening-chemical probe-biology data. These user interfaces will put the MLP data, the results of meta-analysis, and chemical probes within the relevant cellular/pathway context for biologist and computational scientist needs, and small molecule structure-centric interfaces for medicinal and organic chemist needs.

C.)  Enable analysis tools of image based and other novel assay formats (both high and low throughput).  This is one of the critical limiting factors in the application of these data-rich formats to HTS.

D.)  Provide and benchmark cheminformatics capabilities for selection of compounds for the MLSMR and library enrichment initiatives.

E.)  Integrate primary and derivative results from the MLPCN centers (including those in PubChem) with gene/protein expression and structural biology data, map these onto disease-related biochemical pathways.

F.)   The CRCs will emphasize training and education to provide the cheminformatics scientists who will be able to utilize the MLP data in its entirety and make it accessible to non-informatics expert biologists and chemists.

G.)  If appropriate, collaborate with MLPCN centers to implement novel informatic strategies to improve center decision making. Tools and algorithms that would help with the interpretation of cell-based and phenotypic assays would be especially useful. It is important to emphasize that the MLPCN centers are production oriented and therefore attempting to implement methods there that are still very much in the research phase in not appropriate.

H.)  There would be a need for the development of appropriate software development and dissemination environment(s), along with moderated repository(ies) that would allow geographically diverse teams to collaborate.

The above list is intended to be exemplary rather than exhaustive or prescriptive. The applicant can profitably consult the other PAR/RFAs associated with the other initiatives that constitute the MLP. These can be found at http://nihroadmap.nih.gov/molecularlibraries/grants.asp. The CRCs will be funded and managed as cooperative agreements to ensure the coordination essential for the successful attainment of MLP objectives and to enable interoperability of software, databases, and ontologies generated by the centers. Another important reason for a cooperative agreement is to avoid duplication with established commercial solutions that currently exist in some areas (of primary interest to the pharmaceutical industry). The details on the cooperative agreements will be provided in the FOA that is anticipated to be published in the next few weeks.

Approaches Being Sought to Achieve the Objectives

Each of the CRCs will include certain critical functions,

  1. Conducting significant research in computational algorithms that would relate chemical structure to cellular biology, i.e., chemical biology (including benchmarking them).
  2. Conducting significant software engineering infrastructure development to enable the cheminformatics community to collaborate, distribute, and deploy its user interfaces, tools and algorithms.
  3. Enhance the next generation of cheminformatics scientists through training of postdoctoral fellows and graduate students beyond the work they do for specific projects. For example, software engineering training for computational scientists and or chemical biology training for computer scientists.
  4. Dissemination of the tools and GUI built by the centers to the broader bench-scientist (both chemists and biologists) as well as building bridges with the computational biology and bioinformatics communities.
  5. Administration and management to provide structure, and organization to the center and its interactions with the other MLP initiatives and the NIH.

The applicant is free to organize the proposed center in terms of separate Cores or in any other manner deemed appropriate. However, the application must clearly address how the proposed organization of the center will ensure that each of these functions is effectively accommodated.

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

Section II. Award Information


1. Mechanism of Support

The pre-application submitted in response to this announcement will not result in an award using any of the traditional NIH mechanisms. A highly meritorious pre-application will result in an invitation to submit a full center application. For tracking purposes, each pre-application will be assigned a number that will use the X02 mechanism.

2. Funds Available
Not Applicable 

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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

Not applicable

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

A principal investigator, PI, can participate in only one pre-application. There are no limits on the number of pre-applications that can be submitted by one organization.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan

Optional Components:
PHS398 Cover Letter File

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  May 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 7, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  June 28, 2007
Peer Review Date(s): Sept-Oct, 2007 
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): Not Applicable
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: June 29, 2007

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:

Ajay, Ph.D.
NHGRI
5635 Fishers Lane
Suite 4076, MSC 9305
Rockville, MD 20892-9305 (regular mail)
Rockville, MD 20852 (courier mail)
Telephone: (301) 496-7531
Email: ajaydr@mail.nih.gov

Applicants are strongly encouraged to send the letter of intent by e-mail. Please do not submit the same letter by multiple routes (e-mail, FAX, or hard copy).

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Not applicable.

6. Other Submission Requirements

The application for a CRC center must include the following five critical functions, (1) Conducting significant research in computational algorithms that would relate chemical structure to cellular biology, i.e., chemical biology (including benchmarking them), (2) Conducting significant software engineering infrastructure development to enable the cheminformatics community to collaborate, distribute, and deploy its user interfaces, tools and algorithms, (3) Enhance the next generation of cheminformatics scientists through training of postdoctoral fellows and graduate students beyond the work they do for specific projects. For example, software engineering training for computational scientists and or chemical biology training for computer scientists, (4) Dissemination of the tools and GUI built by the centers to the broader bench-scientist (both chemists and biologists) as well as building bridges with the computational biology and bioinformatics communities, (5) Administration and management to provide structure, and organization to the center and its interactions with the other MLP initiatives and the NIH.

In order to ensure effective review, the Research plan should be divided into sections according to the above-defined functions. A total page limit of not more than 20 pages should be adhered to in responding to this X02. Software development should be well-described, with timelines for alpha testing, beta testing, production release, interface development, bug reporting, integration with other codes, extension to multiple platforms, user support, etc. The application should begin with an overview section that provides an executive summary of the application. This overview will be counted toward the 20 page limit. Page limits will be enforced, and it is anticipated that applications that do not adhere to the limits will be declared non-responsive and returned without review.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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 expects that grant 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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

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). See Section VI.3., “Reporting.”

Plan for Sharing Software

A software dissemination plan, with appropriate timelines, will be a criterion for the CRC review but not for the X02 review. Hence software sharing plans should not be included in the X02 application.

The following text in this subsection is included for informational purposes. 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:

  1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  2. The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  3. The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center.  A Center should take responsibility for creating the original and subsequent “official” versions of a piece of software, and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others.  This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.

The application MUST include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including sub-contractors), 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.  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 proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of competing renewal application and annual non-competing progress reports will include assessment of the responsiveness to NIH guidelines of data, materials, methods, and software dissemination practice by the principal investigator.

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 NHGRI in accordance with the review criteria stated below.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, that drive this field? Evaluate how the computational and biochemical problems proposed by the applicant achieve the overall MLP goals.

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
PD/PI(s) and other key personnel 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 PD/PI(s) and investigative team bring complementary and integrated expertise to the project?

Environment: Do(es) the scientific environment(s) 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 employ useful collaborative arrangements? Is there evidence of institutional support?

For the X02 application:

Will the work proposed help establish an integrated environment for doing computational science software engineering and training? 

Will the proposed work establish the center as an essential resource for the wider cheminformatics community and/or experimental scientists involved in chemical-biology/drug-discovery work? 

Is the proposed work essential for establishing a center of excellence in cheminformatics? 

Will the proposed center effectively meet the goals of the CRC and MLP as a whole? 

What are the qualifications, experience, and commitment of the personnel involved in the computational science, software engineering, and training missions.

Is there evidence of an effective approach to managing the interactions between the software engineering parts of the Center and computational and algorithmic parts? 

Will the proposed training help create a new group of multi-disciplinary or interdisciplinary investigators? 

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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 “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
 
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 “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

2.B. Additional Review Considerations

In addition to peer review, when making decisions about which teams will be invited to submit center applications, the Molecular Libraries Implementation Group will also consider  the scientific merit of the proposed project as determined by peer review and the relevance to program priorities.

2.C. Sharing Research Data

Described above in Section IV, subsection 6.

2.D. Sharing Research Resources

Described above in Section IV, subsection 6.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, a written critique called a summary statement will be available on the NIH Commons, https://commons.era.nih.gov/commons/. Those applicants who will be invited to take part in the Limited Competition for the Cheminformatics Research Centers will be notified by telephone or e-mail no later than November 2007. Applicants who are not going to be invited to submit a full consortium application will be notified by e-mail.

Applicants who have concerns about the critique of their application must send their concerns to Dr. Ajay no later than two weeks after the release of their summary statement. Since time will be short, e-mail is strongly preferred as the way to send your concerns to NIH. The two week time period will allow the concerns to be considered by the Molecular Libraries Implementation Group when determining which teams will be invited to submit a full application. Summary statements will not be mailed to applicants, so applicants should make sure that they are monitoring the NIH Commons for the release of the summary statements. The contact information for concerns is:

Ajay, Ph.D.
NHGRI
5635 Fishers Lane
Suite 4076, MSC 9305
Rockville, MD 20892-9305 (regular mail)
Rockville, MD 20852 (courier mail)
Telephone: (301) 496-7531
Email: ajaydr@mail.nih.gov

Section VI. Award Administration Information


1. Award Notices

Not Applicable.

2. Administrative and National Policy Requirements

Not Applicable.

3. Reporting

Not Applicable.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Answers to common questions will be consolidated on a specific web site which can be found here: https://mli.nih.gov/technology/CRC_FAQ.htm. Applicants are encouraged to consult this page frequently as it will be updated frequently. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Ajay, Ph.D.
NHGRI
5635 Fishers Lane
Suite 4076, MSC 9305
Rockville, MD 20892-9305 (regular mail)
Rockville, MD 20852 (courier mail)
Telephone: (301) 496-7531
Email: ajaydr@mail.nih.gov

2. Peer Review Contacts:

Ken Nakamura, Ph.D.
NHGRI
5635 Fishers Lane
Suite 4076, MSC 9305
Rockville, MD 20892-9305 (regular mail)
Rockville, MD 20852 (courier mail)
Telephone: (301) 496-7531
Email: nakamurk@exchange.nih.gov

3. Financial or Grants Management Contacts:

Cheryl Chick
NHGRI
5635 Fishers Lane
Suite 4076, MSC 9305
Rockville, MD 20892-9305 (regular mail)
Rockville, MD 20852 (courier mail)
Telephone: (301) 496-7531
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 (45 CFR 46) 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.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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