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
NIH Common Fund/Office of the NIH Director http://dpcpsi.nih.gov/osc/
National Cancer Institute (NCI), http://www.cancer.gov/
National Heart, Lung, and Blood Institute (NHLBI), http://www.nhlbi.nih.gov/
National Human Genome Research Institute (NHGRI), http://www.genome.gov/
National Institute on Aging (NIA), http://www.nia.nih.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA), http://www.niaaa.nih.gov/
National Institute of Biomedical Imaging and Bioengineering  (NIBIB),(http://www.nibib.gov)
National Institute on Drug Abuse (NIDA), http://www.nida.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/index.shtml
National Institute of Neurological Disorders and Stroke (NINDS),http://www.ninds.nih.gov/
National Library of Medicine (NLM), http://www.nlm.nih.gov/
National Center for Complementary and Alternative Medicine (NCCAM), http://nccam.nih.gov/

Title: National Centers for Biomedical Computing (U54)

Announcement Type

This is a reissue of RFA-RM-04-022.

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

Request For Applications (RFA) Number: RFA-RM-09-002

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release Date: November 10, 2009
Letters of Intent Receipt Date: December 9, 2009
Application Receipt Date: January 8, 2010
Peer Review Date: May-June, 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 1, 2010
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: January 9, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Increasingly, the most exciting science and the most fruitful scientific and technical approaches to biomedical and behavioral research require approaches that involve biomedical informatics and computational biology as well as experimentation.  To meet the infrastructure needs of modern biomedical and behavioral research, the NIH has embarked on a long-term initiative aimed at deploying an integrated national biomedical computing environment.  This environment will enable the analysis, modeling, understanding, and prediction of dynamic and complex biomedical systems across scales of time and space and will allow the integration of biomedical and behavioral data and knowledge at all levels of organization.  All applications in response to this announcement will be evaluated primarily for the potential of the proposed activities to contribute to this long-term goal.

This RFA provides for an open competition for National Centers for Biomedical Computing (NCBC) in the service of this long-term initiative.  Both existing NCBC and new applications for Centers will be entertained.  Information about existing program can be found at http://www.bisti.nih.gov/ncbc. All NCBC will be charged with core responsibilities in implementing and coordinating a national project to develop, improve, and integrate components of biomedical computing.  For example, a particular Center could focus on algorithms, software development and engineering, modeling and methods of validation, definition of hardware requirements, and user interface development to provide an excellent computational environment for one or more classes of biomedically important computing, such as:

Comparative genomics

Biomolecular modeling and simulation

Analysis and modeling based on high throughput experimental techniques

Image analysis, reconstruction, and validation methods

Heterogeneous data integration

Clinical trial management

Epidemiological analysis and modeling

Use of biomimetic principles in device design

Multiscale modeling and simulation of biological processes

Computational and information frameworks for integrating biological, clinical and behavioral data

Genome-phenome linkages

The above list is intended to be exemplary rather than exhaustive or prescriptive. 

These Centers, in conjunction with individual investigator awards, are creating a computational infrastructure for biomedical computing.  The current program and opportunities for individual investigator awards are described in the announcements PAR 08 184 (R01 mechanism http://grants.nih.gov/grants/guide/pa-files/PAR-08-184.html) and PAR 08 183 (R21 mechanism http://grants.nih.gov/grants/guide/pa-files/PAR-08-183.html).

Each NCBC Center should be constructed by considering the entire range of computational techniques that apply to a particular biomedical issue.  In these environments all the relevant computational techniques will be embodied in components that are robust, efficient, easy to use, widely disseminated, interoperable, versatile, in conformity with best practices in software engineering, and well tuned to the most appropriate and powerful free-standing hardware and grid computing environments.  Although the NCBC as a whole will be aimed at solving a large, long-term problem, each individual Center will be focused on solving smaller problems in a five- to ten-year time frame.

Organizational Structure of the NCBC: 

Each NCBC Center will be required to perform or facilitate six different Core functions:  (1) conducting significant research in relevant computational science, such as algorithm creation and optimization, development of hardware architectures applicable to the solution of biomedical problems, and conducting significant research and development in biomedical computational science by developing and deploying tools designed to solve particular biomedical problems; (2) establishing Driving Biological Projects (DBP) to allow experimental and clinical biomedical and behavioral researchers to interact with and drive computational research in the Center; (3) providing infrastructure to serve the needs of the broad community of biomedical and behavioral researchers seeking access to the Center’s tools and resources; (4) enhancing the training for a new generation of biomedical researchers in appropriate computational tools and techniques; (5) disseminating newly developed tools and techniques to the broader biomedical research community; and (6) providing an administrative Core to ensure that the large Center achieve its goals within the the proposed grant period of the NCBC.

The NIH NCBC will be national in scope and function as evidenced by the DBPs, dissemination efforts, training, and potential for future collaborations.

Core 1 in an NCBC Center should propose research that is important to biomedical or behavioral researchers as well as to researchers in computer science and/or computational biology.  This Core will be the largest component of a Center.  The chosen research problem should be significant, but it should also be possible to achieve substantial progress in the timeframe of the award.  It is expected that the personnel associated with Core 1 will have a combination of computer science and biomedical or behavioral research experience.  Core 1 will comprise approximately half of the overall budget.

The NCBC will need cutting-edge computer science and strong leadership in translating that computer science into effective algorithms and environments for solving real biological problems.  Reviewers will evaluate applications for evidence of strong synergy between the computational and biomedical efforts. 

In Core 2, an investigator will propose two to four collaborations with NIH funded biomedical or behavioral researchers to address a biomedical/behavioral question using computational approaches to serve as DBPs.  It is not essential that the biomedical researchers have expertise in computational biology, but they must have a question that will drive the fundamental computational research in Core 1.  The purpose of the DBPs is to ensure that the research carried out in Core 1 has direct relevance to biomedical or behavioral research.  It may be useful for these DBPs to have a focus on a particular disease or organ, but that sort of focus might not be appropriate for all of the Centers.  It is expected that many of the biomedical researchers in Core 2 will not be at the same institution as the parent Center.  In such cases, convincing plans for collaboration at a distance must be presented in the application.  If the problem addressed by the DBP is not going to be completely solved in a three-year period, the Principal Investigator and collaborating researchers must present plans to compete for independent funding for continuation of the work.  Plans must also be presented to recruit and select additional DBPs when the initial proposed DBPs under the Center have been completed.  The plans for retiring and selecting new DBPs should be presented in Core 6, and each DBP originated during the course of the award is subject to the approval of the cognizant Program Officer.  While no distribution of expenditures is mandated, it is envisaged that approximately one-quarter of the budget in each Center will be used to support the participation of the DBPs.  Funding for DBPs should be requested in all five years, and it is expected that each program will maintain a DBP program throughout the entire award period. The new DBPs in years 4 and 5 of the application will not be described in the application, so the presented budgets will be estimates based on the costs of the DBPs in years 1 through 3. 

The new tools that are being developed are likely to require substantial infrastructure to allow the larger community of biomedical researchers to utilize these tools.  Core 3 will provide that infrastructure.  Examples of the infrastructure include user support personnel, servers from which users can download software or through which users can access the software on a national or regional facility, technical support to a national or regional facility on which users use the software, or related items to enable biomedical researchers to have ready access to the products of a Center. 

The long-term goals of the NIH in bioinformatics and computational biology include the development of a new generation of multi-disciplinary biomedical computing scientists.  In Core 4, each Center should propose specific and detailed plans to ensure that graduate students and postdoctoral fellows receive broad relevant training beyond the specific contributions they make to the infrastructure and research projects of the Center.  This training should occur in both directions.  Students and postdoctoral fellows with a background in computational science should receive training in biomedical and behavioral science and those with a background in biomedical and behavioral science should receive training in computational sciences.  In addition, plans should be presented for workshops or other activities to train the larger biomedical community about the new tools and techniques that the Center is developing.  It may be most effective if some workshops occur in the context of important biomedical or behavioral science meetings, at universities or medical schools, or using web-based meetings rather than workshops at the Center itself.  The rationale for the structure and venue of the workshops should be carefully thought out and presented in the application.

The focus of Core 5 is to describe plans to disseminate discoveries, resources, software, and data to the biomedical community.  Publications and a good web site are excellent ways to broadcast some of the discoveries of the Center, but those routes may not be sufficient to inform biomedical and behavioral investigators who require guidance in pursuing computational solutions to their questions.  Innovative plans to disseminate discoveries to this biomedical community should be presented in Core 5.  Applicants must also present their software dissemination plans in Core 5.  They must describe how software will be made available to the general scientific community and justify any restrictions they might place on software dissemination. As part of the software dissemination plan, letters from appropriate institutional officials at all institutions participating in the Center will have to be included.  Finally, plans to make data sets and databases available after funding for the Center has ceased should be presented.

It is essential to describe an appropriate administrative structure to manage the many facets of these large, complex Centers.  This administrative plan should be presented as Core 6.  In this section, specific plans should be included to integrate activities within and across Cores, and to interact with an external community who will be users of the tools created by the Center.  Specific plans for selecting new DBPs should be described.  Investigators are strongly encouraged to consider proposing a project manager for the Center.  In addition to a project manager, it is expected that each Center will have an external advisory committee.  This committee should meet at least on an annual basis to review progress and offer advice.  Potential members of the external advisory committee must not be contacted until after an award has been made, and these members must not be listed in the application.  Core 6 should also address how the Center will accommodate requests from individual investigators who want to make use of the Center via the anticipated individual investigator program announcements. Further, since one of the goals of the NCBC initiative is the creation of a national network support biomedical informatics and computational biology, this core should include plans for participation in the collaborative efforts of various existing and future NCBC Working Groups. Information on the current inter-NCBC Working Groups may be accessed at http://www.bisti.nih.gov/ncbc.

While no distribution of expenditures is mandated, it is anticipated that Cores 3, 4, 5, and 6 will together account for approximately one-quarter of the total budget of a Center.  Taken together, Cores 3 through 6 enable each team to function as an integrated national Center.   

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

Section II. Award Information


1. Mechanism of Support

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

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

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

2. Funds Available

The estimated amount of funds available for support of up to seven projects awarded as a result of this announcement is $24.5 for fiscal year 2010. Future year amounts will depend on annual appropriations.

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

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

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

Section III. Eligibility Information


 1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

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

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The PD/PI is required to devote at least three person months or 25% of his/her time per year to the proposed project. For applications with Multiple PIs, the combined effort of the PIs must total 3 person months per year.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.   

Renewals. Renewal applications for awards that were funded under RFA-RM-04-003 and RFA-RM-04-022 are permitted in response to this FOA. Centers submitting renewal applications are limited to 10 years of total support under this Common Fund program and should propose renewal project periods that do not exceed this limitation.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the Research Plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving Federal Agencies

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

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

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

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

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: December 9, 2009
Application Receipt Date: January 8, 2010
Peer Review Date(s): May-June, 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 1, 2010

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:

Karin A. Remington, Ph.D.         
Center for Bioinformatics and Computational Biology        
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.55H, MSC 6200
Bethesda, MD 20892
Phone: (301) 451-6446
Fax: (301) 480-2554
Email: remingka@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

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

Research Plan Page Limitations

NCBC applications should be structured with the following sections following strict page limits as indicated:

Executive Summary (12 pages, total):

Component Detailed Plans (55 pages, total):

Budget

The budget should be completed as described in the instruction sheet for Application for a Public Health Service Grant (Form PHS 398).  The budget section should begin with an overall budget for the Center using form pages 4 and 5.  After these pages, form pages 4 and 5 should be prepared for Core 1, Core 2, Core 3, Core 4, Core 5, and Core 6.  Separate form pages 4 and 5 should be completed for each of the DBPs in Core 3.  Each budget page should be clearly labeled.  The budget justification should follow the budget for Core 6. This budget justification should include the justification for key personnel. As part of the justification, the amount of effort (in person-months) that all staff spend on each Core should be specified.  For example, a particular postdoctoral fellow might spend 9 person months (or 75% effort) on Core 1 and 3 person-months (or 25% effort) on one DBP in Core 2.  The Principal Investigator of each Center must devote at least 25% of his/her effort.  A justification should be supplied for total equipment over $25,000 requested.  Details of the physical location for such equipment should be provided.  Similar existing equipment should also be described, and the need for the new equipment justified.  Finally, form pages 4 and 5 should be provided for any sub-contractual or consortium arrangements.  A detailed budget justification should also be provided for such arrangements.

Research Plan

Each of the six Cores should be described.  The applicant should use separate headings for each of these Cores.  Cores 1 (conducting core research in computing and conducting core research applying computing to biomedical problems) and 2 (establishing Driving Biological Projects) should be broken into appropriate subheadings.

The annual progress report for the U54 award will use the standard 2590 form as well as supplementary information that will be more extensive.  Additional information in the progress report will include both the progress made in the Center as well as the relationship between the Center and collaborators.  Details of the U54 progress report are spelled out in the Notice of Grant Award and in Section VI.4 of this RFA.  Applications for U54 Centers should request appropriate non-clerical personnel as needed to collect the required information and to prepare this progress report.

Because of the complexity of the NIH NCBC, program staff from NIH may conduct periodic administrative site visits.  U54 Centers should be prepared for an annual site visit and an annual all-hands NIH NCBC meeting, and this should be included in the budget (including travel for collaborators and other necessary costs).

Each Center application is expected to include a well-developed management plan.  If appropriate, the management plan should include provisions for teleconferencing or videoconferencing.

The complexity of these Centers suggests that it may be necessary to request a project manager.  The U54 Centers should budget appropriately for this manager.  One of the review criteria for these Centers will be the qualifications of this project manager as well as whether the institution has an appropriate career pathway for this individual.  Because of this important role, it is recommended that a project manager be listed as one of the key personnel.

Applicants should not contact members of the proposed Center’s external advisory committee prior to award.  Applicants should not name members of the proposed Center’s external advisory committee in the application.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

(d) Plan for Sharing Software: A software dissemination plan, with appropriate timelines, must be included in Core 5 of the application.  There is no prescribed single license for software produced in this project, however reviewers will be asked to evaluate the dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact::

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 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.  The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3.  To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4.  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.  An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.

5.  Given the long-term goals of this initiative to create a national infrastructure for biomedical computing that will serve as a resource to the biomedical researchers across the nation, applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.  This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

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.  These letters should be placed between Cores 5 and 6 and should include a table of contents as described above.

The initial review group will comment on the appropriateness of the proposed plan for data, software, and materials dissemination.  This critique will be factored into the overall score of the application. Program staff and advisors will also consider the adequacy of the dissemination plans as one of the criteria for award. The proposed sharing plans, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of competing renewal applications 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

Review 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 CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How do the computational and biological problems proposed by the NIH NCBC Center make it national in scope? Have DBPs been chosen to drive the biomedical computing work in directions that it may not have gone otherwise? 

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the management plan, including project manager, appropriate for the scope of the Center? Does the management plan outline a detailed and well thought-out strategy for dealing with interactions between the various cores?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition to the above review criteria, as evaluated for each core, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Criteria related to the program’s intent to establish a national infrastructure:

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations.  Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Scientific Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

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

2.A.3. Collaborative Responsibilities

The NIH Project Team will convene an NCBC Steering Committee, with membership appointed by the Common Fund Implementation Working Group, representing the NIH, the Centers, and the broader scientific community, to help coordinate and prioritize the efforts of the national consortium.

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

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The progress of each NIH NCBC Center will be reviewed annually by the NIH Program Officer to assure that satisfactory progress is being made in achieving the project objectives.  During the first year of funding, and during subsequent years if deemed necessary by the Program Officer, reviews may be more frequent.  Should problems arise in the conduct of the study, the NIH Program Officer may require that the awardee submit quarterly reports on progress and fiscal matters. 

The annual progress report should contain the standard NIH progress report (Form 2590) described above, to include a narrative section describing the progress in each of the seven Cores over the past year for the review of the NIH Science Officer(s) and the NIH Program Officer.  The report will also contain at least two “highlights.”  Each highlight will be based on a publication or other product of the Center, less than a year old, which acknowledges support from the National Institutes of Health NCBC.  The highlight will be written at a level that is understandable by a technically literate, but non-expert individual.  The report will also contain details of the federally funded investigators that used the resources in the Center during the preceding fiscal year.  The report will also contain a list of papers that acknowledge support from the NIH NCBC as well as publications that used the Center but did not acknowledge support.  These two lists of publications will be presented separately.

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Karin A. Remington, Ph.D.         
Center for Bioinformatics and Computational Biology        
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.55H, MSC 6200
Bethesda, MD 20892
Phone: (301) 451-6446
Fax: (301) 480-2554
Email: remingka@mail.nih.gov

2. Peer Review Contacts:

George Chacko, Ph.D.
NIH Center for Scientific Review
6701 Rockledge Drive, Room 5170
Bethesda, MD 20892
Phone: (301) 435-1245
FAX: (301) 480-1988
Email: chackoge@csr.nih.gov

3. Financial or Grants Management Contacts:

Grace Olascoaga
National Institute of General Medical Sciences
45 Center Drive, Room 2AN 50B, MSC 6200
Bethesda, MD 20892-6200
Phone:  (301) 594-5520
Fax:  (301) 480-2554
Email: olascoag@nigms.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.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.

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

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

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

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

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

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

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

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


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