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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/ )
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov) - Discontinued participation as of October 16, 2006
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)

Title: Collaborations with National Centers for Biomedical Computing

Announcement Type

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-05-063

Catalog of Federal Domestic Assistance Number(s)
93.286, 93.279, 93.309, 93.859, 93.821, 93.862, 93.396, 93.394, 93.121, 93.242, 93.853, 93.279, 93.879, 93.233, 93.837, 93.838, 93.839, 93.392, 93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399, 93.113, 93.114, 93.273

Key Dates
 Release Date: March 4, 2005
Letters of Intent Receipt Date(s): April 19, 2005; December 19, 2005; April 19, 2006; December 19, 2006; April 19, 2007; December 19, 2007; April 19, 2008; December 19, 2008
Application Receipt Dates(s): May 17, 2005; January 17, 2006; May 17, 2006; January 17, 2007 ; May 17, 2007; January 17, 2008
Peer Review Date(s): October-November, June-July
Council Review Date(s): January 06, September 06, January 07, September 07, January 08, September 08
Earliest Anticipated Start Date: April 1, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 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(s) of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of this program announcement is to provide support for investigators working in collaboration with the NIH Roadmap for Medical Research National Centers for Biomedical Computing (NCBC) using the R01 mechanism. Details about the specific NIH NCBCs already awarded can be found at http://www.bisti.nih.gov/ncbc/. A brief description of the programmatic rationale for the NIH NCBCs is provided in the following two paragraphs:

The NIH Roadmap for Biomedical Research is an integrated vision to deepen our understanding of biology, stimulate interdisciplinary research teams, and reshape clinical research to accelerate medical discovery and improve people's health. The NIH NCBCs are the hubs of a networked national effort to build the computational infrastructure for biomedical computing in the nation, the National Program of Excellence in Biomedical Computing (NPEBC). The NPEBC was described by the BISTI working group (http://www.nih.gov/about/director/060399.htm) and is the central component of the Bioinformatics and Computational Biology Roadmap (http://nihroadmap.nih.gov/bioinformatics/index.asp). The NIH NCBCs are devoted to all facets of biomedical computing, from basic research in computational science to providing the tools and resources (hardware, software, and staff) that biomedical and behavioral researchers need to do their work. In addition to carrying out fundamental research, the NIH NCBCs play a major role in educating and training researchers to engage in biomedical computing. They provide tools and resources that biomedical and behavioral researchers can use at a variety of levels. The NIH NCBCs are partnerships, bringing together three types of scientists: 1) computational scientists, who invent and develop efficient and powerful languages, data structures, software architectures, hardware, and algorithms for solving biomedically significant computing problems; 2) biomedical computational scientists, who adapt and deploy resources from computational science to solve significant biomedical problems; and 3) experimental and clinical biomedical and behavioral researchers, who generate data that can be transformed into knowledge by computational simulation, analysis, modeling, data mining, and visualization. These partnerships are designed to produce, validate, and disseminate tools and computational environments that will be useful to a broad spectrum of biomedical researchers across the nation. The partnerships are highly interactive. Computational scientists work with biomedical or behavioral researchers to develop the tools while the biologists validate these tools and provide feedback for the next generation of tools. In some cases, the NIH NCBCs enhance and extend existing tools; in other cases they develop new tools and computational environments de novo. A detailed description of the work being funded by the NCBC is available at http://www.bisti.nih.gov/ncbc/index.cfm.

The major goal of this program announcement is to provide the resources for a wide range of biomedical, behavioral, and computational researchers to establish new collaborations with the NIH NCBCs. These collaborations should not be a continuation or renewal of a previous collaborative relationship as these collaborations are intended to broaden both the biological and computational expertise of the NIH NCBCs. While collaborations with researchers at the same institution as the NIH NCBC are not explicitly forbidden, they are discouraged and will receive lower programmatic priority since the NIH NCBCs are meant to be national in scope rather than regional. These collaborations are meant to expand the scope of biological problems currently being addressed by the NIH NCBCs and to offer a mechanism to bring the computational expertise of the NIH NCBCs to these new areas of biomedical and behavioral science.

Each NIH NCBC provides tools and resources that biomedical and behavioral researchers can use. To ensure that these tools are useful and responsive to the needs of the biomedical and behavioral community, several mechanisms exist within the NCBC itself to promote collaborations between an NIH NCBC and these communities. These mechanisms include the training and dissemination activities of each NIH NCBC as well as the Driving Biological Projects that are funded within each NIH NCBC. This program announcement provides an additional major mechanism to promote collaborations between biological and behavioral researchers, on the one hand, and computational scientists. There are several major goals of the collaborations to be supported by this announcement:

Areas of biomedical research likely to make use of the NIH NCBCs include but are not limited to:

Some examples of collaborations that this announcement might support include but are not limited to:

For example, there might be two software tools that accomplish a similar function, but have different strengths and weaknesses. One of the tools being developed by investigators at a National Center might scale better on massively parallel computers but the other, being developed by a different group, might have more extensive tools for analyzing the results of the computation. It would be suitable to propose that the author of the other tool enter into a collaboration with the National Center to produce a tool that has the best features of both, to the benefit of the national user community.

As another example, there might be two tools authored by two different groups that simulate the same system, but on different time and length scales, and one of the tools is authored by the PI or a co-investigator of a National Center. It would be suitable to propose collaboration between the National Center and the author of the other tool to create a single, integrated, multi-scale tool that would combine the capabilities of both tools.

Each NIH NCBC was funded for a five-year period, and has the possibility for a single five-year renewal. Your application must recognize this timeline. Your proposed research must either be complete when the center ends, or you must request sufficient resources for continuing to support the components of the NIH NCBC that will be required beyond the lifetime of the center. Support to build long-term on the proposed work beyond the lifetime of the NCBC can be requested under the normal unsolicited NIH research program or via appropriate program announcements or requests for applications.

As an individual investigator, you must work closely with an NIH NCBC in developing your application. A list of the research areas and contact information for each NIH NCBC can be found at http://www.bisti.nih.gov/ncbc/. When developing your application, you should carefully consider the personnel, instrumentation, supplies, or other expenses at the NIH NCBC as well as in your laboratory. A letter of support from the PI of the collaborating NIH NCBC is required for your application. Since the National Centers are cooperative agreements, the NIH is an active partner with the PI of the NIH NCBC in the operation of the NCBC. Therefore the Program Officer and the Lead Science Officer of the NCBC should be copied on communications to the NIH NCBC PI regarding a proposed collaborating project under this funding announcement. The names of the NIH Program Officer and Lead Science Officer for each NIH NCBC can be found at http://www.bisti.nih.gov/ncbc/.

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 R01 award mechanism. 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 as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

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:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

No cost sharing is 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

A letter of support is required from the NIH NCBC with which you plan to collaborate. This letter should identify the resources that the NIH NCBC will contribute to the collaboration in addition to the resources requested in the application. The letter must come from the PI of the center.

There is no limit to the number of scientifically distinct applications an applicant may submit under this announcement.

The intent of this solicitation is to fund new collaborations that substantially increase both the breadth and application of the NCBCs. Therefore, any application that continues an ongoing collaboration, originates from the same institution as the collaborating NCBC, or which fails to bring new biological or computational expertise to the national network will receive low programmatic priority and must be judged to offer a unique opportunity in order to be considered for funding.

The application must include written statements from the officials of the applicant institutions responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application. Typically, the relevant responsible official will be in the applicant institution's office of technology transfer or intellectual property, as opposed to an academic official such as a department head or dean. Failure to include such a statement will result in the application being declared nonresponsive to this announcement, and being returned to the applicant without review.

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) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

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

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

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 19, 2005; December 19, 2005; April 19, 2006; December 19, 2006; April 19, 2007; December 19, 2007; April 19, 2008; December 19, 2008
Application Receipt Date(s): May 17, 2005; January 17, 2006; May 17, 2006; January 17, 2007 ; May 17, 2007; January 17, 2008
Peer Review Date: October-November, June-July
Council Review Date: January 2006, September 2006, January 2007, September 2007, January 2008, September 2008
Earliest Anticipated Start Date: April 1, 2006

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:

Kevin Lauderdale
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AN24, MSC 6200
Bethesda, MD 20892-6200
Telephone: 301-594-4499
FAX: 301-480-2802
Email: [email protected]

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 five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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 CSR and responsiveness by the NCBC Project Team.

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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

Each application should include a section of up to five pages in length describing the NCBC with which the proposed project will collaborate. The purpose of this section is to make the application completely self-contained, so that a reviewer will not need to consult any material other than the application itself in order to judge its merit, and in particular so that the reviewer will not need to consult the Web site of the partnering NCBC. This section is in addition to the 25 pages allotted for the Research Plan, (that is, the total allowed pages are 25 plus another 5 for this extra section) and should immediately precede the Research Plan.

Each application must include a timeline and a set of milestones that are expected to be achieved by the end of the research. This section should have a separate title and should follow the Research Design and Methods section. The timeline and milestones section must be contained within the 25 page limit for the research plan.

Because of the complexity of the NIH NCBC, program staff members from NIH will likely conduct administrative site visits to the centers on at least an annual basis. Investigators funded under this program announcement should plan to take part in annual site visits to the collaborating NCBC and should budget appropriately.

A software dissemination plan must be included in the application, if support for development, maintenance, or enhancement of software is requested 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:

1) The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutes, 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 NCBC and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the center. Applications responding to this announcement should describe how any software supported by this announcement will be integrated in the computational environment developed by the collaborating NCBC. During the life of the NCBC, the NCBC should take responsibility for national dissemination of any software created by the proposed collaborative project, as part of the overall computational environment that the NCBC will provide for the nation. The application must include written statements from the officials of the applicant institutions responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the proposal. Typically the relevant responsible official will be in the applicant institution's office of technology transfer or intellectual property, as opposed to an academic official such as a department head or dean. Failure to include such a statement will result in the application being declared nonresponsive to this announcement, and being returned to the applicant without review.

4) The software must be in a form such that if the applicant team loses interest in the software subsequent to the life of the project another individual or team can make use of previous work to continue development and maintenance.

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.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement (Type 3), or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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.

Reviewers will be instructed to evaluate the dissemination plan for sharing software developed in the proposed project in accord with the following goals:

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. 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 grantee.

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 submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

The following will be considered in making funding decisions:

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

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

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

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

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

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

2.A. Additional Review Criteria:

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

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.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.

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.

The NGA will be sent electronically or via hard copy to the authorized business official at the grantee institution.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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.

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:

For general programmatic inquiries:

Eric Jakobsson, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
Building 45, Room 2As.55H, MSC 6200
45 Natcher Drive
Bethesda, MD 20892-6200
Telephone: (301) 594-5236
Email: [email protected]

For inquires specific to particular Institutes or Centers, contact an individual in that Institute or Center from the following list:

David M. Balshaw, Ph.D.
Center for Risk and Integrated Sciences
National Institute for Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: 919-541-2448
Email: [email protected]

Jennifer Couch, Ph.D.
Cancer Diagnosis Program
National Cancer Institute
EPN - Exec Plz North, Room 5004, MSC 7420
6130 Exec Blvd
Rockville, MD 20892-7344
Telephone: 301-435-5226
Email: [email protected]

Charles P. Friedman, Ph.D.
Senior Scholar & Program Officer, NLM Extramural Programs
RKL1 - One Rockledge Ctr, Room 301
6705 Rockledge Drive Suite 301
Bethesda Md 20892
Telephone 301-594-4882
Fax: 301-402-2952
Email: [email protected]

Eleni Kousvelari
Center for Biotechnology and Innovation
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN 18A
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-2427
FAX: (301) 480-8318
Email: [email protected]

Michael F. Huerta, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
Neuro Science Center, Rm. 7202
6001 Executive Boulevard
Rockville, MD 20852
Phone: 301-443-3563
Fax: 301-443-4822
Email: [email protected]

Yuan Liu, Ph.D.
Neuroscience Center
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Room 2110
Rockville, MD 20852
Telephone : (301) 496-1917
EMAIL: [email protected]

Peter Lyster, Ph.D.
Program Officer
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS 55K, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 451-6446
FAX: (301) 480-2802
Email: [email protected]

Grace Peng, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
Building 2DEM - Two Democracy Plz, Room 200
6707 Democracy Boulevard
Suite 200 MSC 5477
Bethesda, MD 20892
Telephone : 301 451 4772
Fax: 301 480 4973
Email: [email protected]

Karen Skinner, Ph.D.
Division of Basic Neurosciences and Behavioral Research
National Institute on Drug Abuse
Neuroscience Center, Room 4255
6001 Executive Boulevard
Rockville, MD 20852
Telephone : 301 443-1887
Fax: 301 594 6043
E-mail: [email protected]

Michael Twery, Ph.D.
Airway Biology & Disease
National Heart, Lung, and Blood Institute
Two Rockledge Ctr, Room 10116, MSC 7952
6701 Rockledge Dr
BETHESDA MD 20892-7952
Telephone: 301-435-0202
Email: [email protected]

John Whitmarsh, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive MSC 6200
Building 45, Room No. 2As.55F
Bethesda, MD 20892
Telephone: (301) 451-6446
Fax: 301-480-2802
Email : [email protected]

2. Peer Review Contact:

Sally Amero, Ph.D.
Chief, Bioengineering Sciences and Technology IRG
Center for Scientific Review
6701 Rockledge Drive, Room 4190, MSC 7826
Bethesda, MD 20892-7826
Telephone: (301) 435-1159
FAX: 301-480-4042
Email: [email protected]

3. Financial or Grants Management Contacts:

Gary Fleming, J.D., M.A.
Chief Grants Management Officer
National Institute on Drug Abuse
National Institutes of Health
6101 Executive Blvd.
Suite 270, MSC 8403
Bethesda, MD 20892-8403
Telephone : (301) 443-6710
FAX: (301) 594-6849
E-mail: [email protected]
COURIER ADDRESS:
6101 Executive Blvd., Suite 270
Rockville, MD 20852

Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AN 50B, MSC 6200
Bethesda, MD 20892-6200
Phone: (301) 594-5132
Fax: (301) 480-2554
email: [email protected]

Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive MSC 7968
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: (301) 402-0421
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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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