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 Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)

Title: Clinical and Translational Science Coordinating Center (U54)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-RR-10-007

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: July 16, 2010
Letters of Intent Receipt Date: December 15, 2010  
Application Receipt Date: January 12, 2011 
Peer Review Date: June 2011
Council Review Date: September 2011
Earliest Anticipated Start Date: December 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 13, 2011

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
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. Dispute Resolution 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 FOA is to solicit applications for a Clinical and Translational Science Coordinating Center (CTSCC).  The CTSCC will encourage and facilitate sharing and interactions within the CTSA Consortium and of the Consortium with non-CTSA institutions, organizations, and programs also focused on advancing the efficiency and quality of clinical and translational research and training.  The CTSCC will also facilitate communication of CTSA Consortium activities to others.  The CTSCC will provide a web-based site for collaboration, including wikis, forums, and public and private work spaces, to facilitate the communal development and adoption of best practices for conduct of clinical and translational research to enhance quality, efficiency, and value. This Center will also support conference calls and face to face meetings of the CTSA Consortium committees and working groups.  In addition, the CTSCC will provide and manage the public non-government website of the Clinical and Translational Science Consortium to communicate the activities, resources, and best practices of the CTSA Consortium and individual CTSAs across the country to the public, industry, and basic, clinical and translational science investigators and students.  The CTSCC will not provide resources for conduct of research or research projects. This center will facilitate collaboration and communication within the CTSA Consortium and with non-CTSA organizations, including industry, to advance clinical and translational research and training generally and to advance development, sharing, and adoption of best practices in clinical and translational research, training, and outreach.  

Background:  The Clinical and Translational Science Award (CTSA) program provides grants to institutions to create an integrated academic home to train multi- and inter-disciplinary investigators, award advanced degrees in clinical and translational science, and provide investigators and research teams with research cores, tools, and a local environment that encourages and facilitates the conduct of clinical and translational research, including with community and industry partners.  As cooperative agreement grants, each awardee is also required to participate in the CTSA Consortium, whose goal is to reduce the barriers and increase efficiency of multi-institutional clinical and translational research both within the Consortium and with other partners, to share knowledge and disseminate best practices for clinical and translational research widely, and to collaborate together and with others to enhance the national environment for clinical and translational research. The NCRR expects the CTSA Consortium to include 60 CTSA awards (excluding the Coordinating Center). The CTSA Consortium Steering Committee, the core governing and decision making body of the CTSA Consortium, is composed of the PI of each CTSA and trans-NIH representatives.  In addition, there are over 20 major committees, each of which may include a number of working groups.  Committees, focused on key functions of CTSAs such as Community Engagement, Regulatory Knowledge, Translational Research, Biomedical Informatics, allow individuals from CTSAs to share best practices, information, and work on shared projects.  Other committees address specific areas of interest, including advancing pediatric clinical and translational research.  Each Committee generally includes a representative from each of the CTSAs, while working groups are generally smaller. For further information on the CTSA Consortium, see www.ctsaweb.org.

Specific Objectives: The goal of the CTSCC is to provide staff and resources to support the national CTSA Consortium in its activities.  Specific objectives include, but are not limited to:

Special Requirements: 

It is anticipated that the CTSCC will establish an independent External Advisory Committee (EAC) that would annually review the activities, progress, and effectiveness of the CTSCC and provide recommendations to the Principal Investigator.  It is expected that this EAC would include individuals who have experience in managing large coordinating centers, representatives from the various communities served by the CTSCC, and experts in facilitating national collaboration and communication.  The application should include a description of the types of individuals but should not name any potential members and no members should be contacted prior to review of the application. 

As noted in the Section VI.2.A Cooperative Agreement Terms and Conditions of Award, the PI of the CTSCC will participate in the CTSA Consortium Steering Committee as a voting member, and provide updates on current activities and discuss proposed modifications to CTSCC activities and support with the CCSC on at least a quarterly basis.      

The application should address how the proposed management of each specific objective would facilitate the transition of those activities to a potential successor at the end of the five-year project period.  This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the CTSCC.  Inclusion of approaches and activities that would facilitate the transition of the activities and infrastructure of the CTSC, including content of the public website and collaboration site, at the end of the award period is required.

The applicant must include funds for the PI and key personnel to attend the annual two-day CTSA Consortium Steering Committee meeting in the Bethesda area.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U54 award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

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

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

2. Funds Available

Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed activities may vary from application to application, it is anticipated that the size and duration of each award may also vary. Although the financial plans of the NCRR provides 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.

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 program support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit one application.

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

Renewals.  Renewal applications are not permitted in response to this FOA. 

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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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.

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

Letter of Intent Receipt Date: December 15, 2010
Application Receipt Date: January 12, 2011
Peer Review Date: June 2011
Council Review Date: September 2011
Earliest Anticipated Start Date: December 2011

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 NCRR 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:

Office of Review
National Center for Research Resources
6701 Democracy Boulevard
Building Number, Room Number 1084
Bethesda, MD 20892-4874
Bethesda, MD 20817 (FedEX or courier)
FAX: (301) 480-3660
Email: mv10f@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 three signed photocopies in one package to:

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

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

At the time of submission, two additional copies of the application must be sent to:

Office of Review
National Center for Research Resources
6701 Democracy Boulevard, Room 1001
MSC 4874
Bethesda, MD 20892-4874 (Regular Mail)
Bethesda, MD 20817 (FedEX or courier)
Telephone: (301) 435-0811

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 Center. 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 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 award.

The incurrence of pre-award costs in anticipation of a 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

Special Requirements that must be addressed in the application.

The applicant must include funds for the PI and key personnel to attend the annual two-day CTSA Consortium Steering Committee meeting in the Bethesda area.

The application should address how the proposed management of each specific objective would facilitate the transition of those activities to a potential successor at the end of the five-year project period.  This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the CTSCC.  Inclusion of approaches and activities that would facilitate the transition of the activities and infrastructure of the CTSCC, including content of the public website and collaboration site, at the end of the award period is required.

It is anticipated that the CTSCC will establish an independent External Advisory Committee (EAC) that would annually review the activities, progress, and effectiveness of the CTSCC and provide recommendations to the Principal Investigator.  It is expected that this EAC would include individuals who have experience in managing large coordinating centers, representatives from the various communities served by the CTSCC, and experts in facilitating national collaboration and communication.  The application should include a description of the types of individuals but should not name any potential members and no members should be contacted prior to review of the application. 

As noted in the Section VI.2.A Cooperative Agreement Terms and Conditions of Award, the PI of the CTSCC will be a voting member of the CTSA Consortium Steering Committee, and provide updates on current activities and discuss proposed modifications to CTSCC activities and support with the CCSC on at least a quarterly basis.      

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

Organization of the Application:  The Research Strategy section should be organized to address the specific objectives of this funding opportunity:  coordination and administrative support; enabling collaboration; and communication, including management of a public website.  The Research Strategy section should total 30 pages or less and include separate sections for each of the above objectives.

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

No Appendix Materials are allowed.

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, applicants are expected to include a brief 1-paragraph description of how final 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) Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected to be included in the application.  There is no prescribed single license for software produced in this project, however reviewers will be asked to comment on 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 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.

The application is expected to 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 should be clear expressions of commitment consistent with achieving the goals of the program.  A separate letter should be included from each institution or organization, including each subcontractor.   

The initial review group will comment on the appropriateness of the proposed plan for data sharing and the proposed plan for  software sharing.  These comments 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 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.

The following resource sharing policies do not apply to this FOA:

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 NCRR 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 scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored 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.  Will the proposed Clinical and Translational Science Coordinating Center facilitate the coordination, sharing, collaboration, and communication among the CTSAs in the national CTSA Consortium?  Will the proposed Clinical and Translational Science Coordinating Center facilitate the coordination, sharing, collaboration, and communication among the national CTSA Consortium and a broad range of non-CTSA institutions, organizations, and programs?  How will the proposed Clinical and Translational Science Coordinating Center advance the field of clinical and translational science?  

Investigator(s).  Are the PI, collaborators, and other personnel well suited to the project?  Have they demonstrated ongoing records of accomplishments in support of coordination, collaboration, and communication of large national-level consortia or networks?  Do the personnel have complementary and integrated expertise? Are the proposed staffing approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to impact national interaction, collaboration, and communication paradigms by utilizing novel approaches, methodologies, or tools?  Does the application include mechanisms for leveraging novel collaboration and communication strategies?  Does the application indicate creativity and flexibility to innovate on an on-going basis while meeting the objectives of the solicitation? 

Approach.  Are the overall strategy, approach, and implementation well-reasoned and appropriate to accomplish the specific objectives of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?  Will the proposed approach allow rapid deployment and management of a CTSA Consortium public non-government website?  Will the proposed approach allow rapid deployment and use of collaborative tools by the consortium members, committees, and partners?  Are the proposed activities to enhance coordination, collaboration, and communication flexible enough to meet evolving needs of the CTSA consortium and potential new partnerships with non-CTSA groups? Is the plan for administrative support for the CTSA committee synergistic with proposed coordination and collaboration activities? Is the proposed External Advisory Committee constituted to provide independent, thoughtful, creative, and practical recommendations to address challenges and improve performance?  Will the proposed approach and documentation facilitate transition of the content and activities of the coordinating center to a successor at the end of the project period?

Environment.  Does the environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available and adequate to ensure a rapid start and continuing evolution of the proposed support center?  Will the project benefit from unique features of the institutional environment, workforce, or collaborative arrangements? 

Additional Review Criteria

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

Data Sharing Plan.  A data sharing plan is expected to be included in the application as outlined in the Other Submission Requirements section.  The reviewers will comment on the appropriateness and adequacy of the proposed data sharing plan and factor their review into the determination of the overall score.

Plan for Sharing Software. A software dissemination plan, with appropriate timelines, is expected to be included in the application as outlined in the Other Submission Requirements section.  Reviewers will comment on and factor into their overall score the appropriateness and adequacy of the proposed plan for software sharing.  The review should be guided by the following principles thought likely 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 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.

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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Not applicable to this FOA.

Resubmission Applications. Resubmissions are not allowed for this FOA.

Renewal Applications.  Renewals are not allowed for this FOA.

Revision Applications. Revisions are not allowed for this FOA.

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.

Applications from Foreign Organizations. Foreign are not allowed for this FOA.

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).

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.

The following resource sharing policies do not apply to this FOA:

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 official.

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

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for the overall function of the Clinical and Translational Science Coordinating Center.  This includes responsibility for the coordination and administrative support of the CTSA Consortium committees and working groups, enabling collaboration within the CTSA Consortium and with others to facilitate communal development and adoption of best practices, and communication and outreach of the CTSA Consortium, including management of a non-government website for the CTSA Consortium.

The Principal Investigator is expected to participate in all meetings of the CTSA Consortium Steering Committee as a voting member.  In addition, the CTSCC PI will present at least quarterly reports to the CTSA Steering Committee of the current and planned activities of the CTSCC. In addition, the PI will serve as an ad hoc member of the CTSA Consortium Executive Committee and is expected to participate in all meetings.

All software developed in this project must be made available as outlined in the Special Requirements.

2. A.2. NIH Responsibilities

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

The NIH Project Coordinator will serve as a voting member of the CTSA Steering Committee and participate in other committees as appropriate.  The NIH Project Coordinator will facilitate interactions with other NCRR and NIH programs; provide relevant expertise and overall knowledge of NIH-sponsored programs and other projects to facilitate collaboration, and provide input and suggestions when challenges or opportunities arise.  The NIH Project Coordinator will ensure the CTSCC can connect with a wide range of other projects and programs relevant to clinical and translational science.  However, the dominant role and prime responsibility for the project resides with the awardee.


Additionally, an NCRR Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This individual is responsible for coordinating the assessment of the progress.

2.A.3. Collaborative Responsibilities

The Principal Investigator and NIH Project Coordinator will serve as voting members of the CTSA Consortium Steering Committee (CCSC); however, neither may serve as a co-Chair of the CCSC.  The Principal Investigator will also serve as an ad-hoc member of the CTSA Consortium Executive Committee (CCEC) to ensure open communication between the leadership of the CTSA Consortium and the CTSCC. 

The national CTSA Consortium Steering Committee shall be a forum for sharing policies, practices, and resources and for discussion of opportunities, impediments, joint agreement on broad issues impeding clinical research, government policies and practices, and other appropriate topics. The Committee will identify and approve best practices and policies that will advance clinical and translational research as a discipline and facilitate collaboration and sharing among CTSA institutions and with partners in clinical and translational research, e.g., industry, laboratories, hospitals.  Awardee members of the Steering Committee, including the CTSCC, will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter 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

The awardee 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.  This Non-Competing Continuation Grant Progress Report (PHS2590) may be required to follow Special Instructions from NCRR for Center-like programs.  

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:

Renee Joskow, DDS, MPH
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard, Room 923  
Bethesda, MD 20892-4874
Telephone: (301) 435-0961
Email: joskowr@mail.nih.gov

Elaine Collier, MD
Office of the Director
National Center for Research Resources
Democracy One, Room 998
6701 Democracy Boulevard Avenue

Bethesda, MD 20892
Telephone: (301) 435-0794
Email: ec5x@nih.gov

2. Peer Review Contacts:

Dr. Mohan Viswanathan
Office of Review
National Center for Research Resources
6701 Democracy Blvd
Democracy 1, Room Number 1084
Bethesda, MD 20892
Telephone: (301) 435-0829
Email: mv10f@nih.gov

3. Financial or Grants Management Contacts:

Vicki Maurer
Office of Grants Management
National Center for Research Resources
6701 Democracy Boulevard, Room  1042
Bethesda, MD 20892-4874
Telephone: (301) 435-0837
Email: maurervl@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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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