Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
This RFA is developed as an NIH Roadmap Initiative. All Institutes and Centers participate in Roadmap Initiatives. The RFA will be administered by NCRR on behalf of the NIH.

Title: Planning Grants for Institutional Clinical and Translational Science Awards

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-RM-06-001

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: October 12, 2005
Letters of Intent Receipt Date(s): February 27, 2006
Application Receipt Dates(s): March 27, 2006
Peer Review Date(s): Summer, 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: March 28, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Purpose: This RFA invites applications to support planning activities to design Institutional Clinical and Translational Science Award programs (CTSAs). The goal of the Institutional CTSA program (which is described in RFA-RM-06-002) is to create an academic home (as a Center, Department, Institute or other) environment that will develop the discipline of clinical and translational science, increase the efficiency and speed of clinical research, and train the next generation of clinical and translational scientists. The purpose of this RFA is to provide resources to allow institutions to develop a plan for the content, governance, administration and evaluation of a CTSA, and to manage the necessary organizational and cultural changes needed to implement the program. Planning activities are intended to lay the foundation and prepare institutions for submitting a subsequent CTSA application.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
   1. Research Objectives

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

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

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

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

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   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

Purpose of this RFA:

This RFA invites applications to support planning activities to design Institutional Clinical and Translational Science Award programs (CTSAs). The goal of the institutional CTSA program (which is described in RFA-RM-06-002) is to give the flexibility and stimulus for institutions to increase the synergy of their existing resources and talent and to propose ways to increase the efficiency and speed of clinical and translational research. This goal may be easier to reach if such efforts are conducted within a true academic home, comprising a dedicated faculty and staff who share a transformative vision, mission and strategy. The academic home, which can be a Center, Department, or Institute (C/D/I), is expected to include faculty who conduct original research, develop graduate and postgraduate training curricula and lead programs that integrate clinical and translational science across multiple departments, schools, clinical and research institutes and hospitals. The purpose of this RFA is to provide resources to allow institutions to develop a plan for the content, governance, administration and evaluation of a CTSA, and to manage the necessary organizational and cultural changes needed to implement the program. Planning activities are intended to lay the foundation and prepare institutions for submitting a subsequent CTSA application.

CTSAs will provide resources and develop methodologies intended to overcome blocks at both the discovery (translational between bench and bedside) and implementation (translation between bedside and practice) steps. For the purpose of this initiative, ‘Clinical research' comprises studies and trials in human subjects meeting the NIH definition in the PHS 398 instructions. Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in human studies. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. The term ‘science' is meant to encompass the discovery of new knowledge about health and disease prevention, pre-emption, and treatment; as well as methodological research to develop or improve research tools.

To enable institutions to assess the adjustments that would be needed to create an integrated CTSA program, this Request for Applications (RFA) solicits applications for P20 planning grants that will allow institutions to develop the content and governance for a CTSA program, as well as develop a plan to manage needed institutional organizational and cultural changes. The CTSA program that is planned, whether housed in a Center, Department, Institute, or other entity, must be non-categorical (i.e., broadly inclusive of different types of clinical and translational research and not limited to any discipline or group of disciplines).

NOTE: RFA-RM-06-002 has been concurrently issued for the CTSA program. Institutions may submit applications for either solicitation but not both simultaneously. The NIH intends to issue solicitations for additional CTSAs in future years, but may not issue additional solicitations for planning grants.

Background:

Scientific opportunities made possible by recent advances in genomics, proteomics, informatics, imaging and other novel methodologies, and the increasing need to conduct research in human populations with the attendant regulatory and organizational complexities inherent to such research, dictate that opportunities for transforming our current approaches be provided to the scientific community. Over the years, NIH has supported the conduct of translational and clinical research through multiple separate programs such as General Clinical Research Centers, specialized laboratories and imaging facilities, funds for new and emerging fields such as research informatics, and the training of generations of translational scientists. These investments, however, fall short of recognizing the important linkages between these resources and the growing need to provide sustained interdisciplinary training in a supportive and dedicated academic and intellectual environment. A distinct discipline of translational and clinical sciences is needed to ensure that the rapid and fundamental advances in biomedical and behavioral sciences will be used in patient-oriented research. The discipline requires well-structured and well-recognized career development pathways that intertwine with original and fundamental research to explore new ground in the methods and approaches to clinical research. This goal may be easier to reach if such efforts are conducted within a true academic home, comprising a dedicated faculty and staff who share a transformative vision, mission and strategy. To evaluate the research resources needed for clinical and translational sciences, NCRR, together with representatives from other NIH Institutes and Centers (ICs) and the NIH Roadmap met on May 23, 2005 , with representatives of academic health centers, industry, and the not-for-profit sector. These discussions (posted at http://www.ncrr.nih.gov) ascertained that substantive resources for clinical and translational research are already being provided by NIH ICs through individual grants; training and career awards; and mission-specific centers. NCRR makes a substantial contribution to the nation's clinical research needs through a network of 78 General Clinical Research Centers (GCRCs) at a total cost approaching $287 million a year, and through clinical research career development programs (K12, K23 and K30, as well as the K24 mentoring program). Discussions focused on institutional needs for environments specifically dedicated to clinical and translational research and the benefits that would come from integration with career development and higher degree opportunities. Participants concluded that an academic home for clinical translational research built on the clinical research resources currently funded by NIH would provide a timely and cost-effective stimulus that would develop clinical translational research as a discipline, expand the numbers of qualified investigators, expand the numbers of participants in clinical research studies and speed the publication of study conclusions.

Planning grants will provide institutions with support to survey their resources and needs so that they can develop comprehensive plans for an Institutional CTSA. Some institutions that already have, for example, higher degree-granting programs in clinical research and an integrated research infrastructure, may consider themselves ready to apply for a CTSA directly, without going through a planning phase. The CTSA planning grant program will work closely in cooperation with other NIH Roadmap initiatives, IC specific activities, and other appropriate trans-NIH initiatives.

Objectives of the Planning Process

Applications should develop plans for the content, administration, governance, and evaluation of an Institutional CTSA program that will provide an intellectual home for clinical and translational science, with the flexibility to integrate into a national CTSA consortium. Key objectives of the CTSA program are to create programs characterized by:

Planning for a CTSA should build on the institution's resources and experience in clinical and translational research, education, and career development, identifying the clinical and translational science community that will be served and describing plans to develop the content, administration, governance, and evaluation of an Institutional CTSA. This might include, for example, a process to identify (1) current career development opportunities for all disciplines participating in clinical research, including higher degrees that can be earned; (2) needed resources, services, and technologies that will serve the clinical and translational research needs of the institution and affiliates; (3) methods that will integrate new and existing resources; and (4) the resources that the applicant institution is willing to commit to the CTSA.

Examples of CTSA research resources:

Applicants should refer to the RFA-RM-06-002 for an Institutional CTSA as they develop their plans. Broad areas that were identified in prior recommendations to the NIH that could serve as a guide include:

Development of Novel Clinical and Translational Methodologies: Original research on novel methodologies and approaches for translational and clinical sciences will be needed if a C/D/I is to build an environment that sustains intellectual exploration. Faculty members could pursue their funded research in new translational methodologies, clinical trial designs, clinical informatics for longitudinal studies, home based research devices and methods, amongst others.

Pilot and Collaborative Translational and Clinical Studies: An applicant could request support for Pilot and Collaborative clinical research projects that allow clinical and translational trainees or researchers to generate preliminary data for submission of a research grant application. These projects should, in general, be of sufficient scope to qualify as a stand-alone research effort and should be well integrated into the activities of the CTSA.

Biomedical Informatics: Plans should anticipate internal information technology and intra-institution interoperability to support clinical and translational research studies and, secondly, external interoperability among the CTSAs and with the necessary research partners of clinical and translational investigators, which could include government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers.

Design, Biostatistics, and Clinical Research Ethics: Plans could support trainees and research teams in research design, analysis, and ethics, and performs research to advance the intellectual knowledge base and improve or develop tools or methods in these areas.

Regulatory Knowledge and Support: Plans could provide for an institutional environment that facilitates protections of human subjects and regulatory compliance; that supports investigators in their compliance with regulatory requirements; and that, in cooperation with other institutions, develops best practices that reduce or remove institutional impediments to clinical and translational research. This activity should not take the place of institution compliance or enforcement offices nor shall it be responsible for Institutional Review Board activities.

Participant and Clinical Interactions: These resources could promote participation in research studies, provide for the recruitment of research participants, in-patient, out-patient, or community-based exam rooms, research nurses, research coordinators, phlebotomists, scheduling services, and services for research specimen collection and distribution. Clinical and translational research projects supported by a wide range of NIH Institutes and Centers should be supported. Resources dedicated to specific diseases, specialties, or appropriate only for limited number of investigators are discouraged.

Community Engagement: Community outreach could foster collaborative partnerships and enhance public trust in clinical and translational research, facilitating the recruitment of research participants from the community. Resources that might be requested include community outreach and cultural sensitivity training for institutional clinical and translational researchers, community and provider education and outreach, development of software to facilitate the collaboration of community practitioners, and communication outlets.

Research Education, Training and Career Development: Plans could include novel methods and approaches for providing an integrated and flexible education, training, and career development environment leading to graduate degrees in clinical and/or translational sciences. The Institutional CTSA provides for integrated Research Education, K12 and T32 components to maximize the opportunities for education. The program should, in general, be broad enough to train those interested in careers in multi-disciplinary team-based clinical and translational science, and for the development and improvement of new research methodologies that advance the discipline.

Governance: An overall governance and structure should be described, together with the plans to identify the individuals who would serve as core directors, together with the mechanisms by which they would ensure that the core directors had the authority to carry out their missions. The plans should propose administrative policies and procedures, advisory committees and include a robust evaluation component.

Institutions are encouraged to be innovative in their assessments of their clinical and translational infrastructure needs, and to add additional components that could transform the conditions under which they advance the discipline of clinical and translational science, conduct their clinical and translational research, and educate multidisciplinary team members.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH P20 ( Exploratory Center ) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NIH Roadmap intends to commit approximately $11.5 million in FY 2006 to fund approximately 50 planning grants in response to this RFA. An applicant must request a project period of 1 year and a budget for direct costs of up to $150,000. Because the nature and scope of proposed centers will vary by application, it is anticipated that the size of each award also will vary. Although the NIH Roadmap budget includes support for these Planning Grants, awards pursuant to this RFA are contingent on the availability of funds and the receipt of a sufficient number of meritorious applications.

This RFA is a one-time solicitation with an anticipated award date of September 2006. Awards will remain active for 1 year, but no-cost extensions of 1 year may be granted.

Allowable costs include salary and benefits, travel, preparing and organizing meetings and conferences in relation to planning for a CTSA.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Domestic institutions, including universities, academic health centers, or other research organizations conducting clinical and translational research are eligible. Institutions and their affiliates (if any) may submit, or be part of, only a single application in response to this RFA. Multiple applications from different divisions, faculties, centers, schools, etc. of the same university or medical school will be returned without further consideration by the NIH. Foreign institutions and foreign components of applications are not allowed. Applications from ineligible institutions will be returned.

1.B. Eligible Individuals

Individuals with the skills, knowledge, and resources necessary to plan, organize, and administer an Institutional CTSA are invited to work with their institution and individuals from partnering institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups and those with disabilities are always encouraged to apply for NIH programs or to partner with principal investigators from other institutions to develop a responsive application.

Individuals should have strong and active records in clinical or translational research, training, and administration that demonstrate the skills, knowledge, and experience necessary to develop and manage the proposed CTSA Planning Grant.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Eligible institutions may either apply for this RFA or the companion CTSA program RFA (RFA-RM-06-002), but not both simultaneously.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times
Applications must be received 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: February 27, 2006
Application Receipt Date(s): March 27, 2006
Peer Review Date: Summer 2006
Council Review Date: September, 2006
Earliest Anticipated Start Date: September 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to e-mailed by the date listed above to:

Bernard Talbot, M.D., Ph.D.
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard
Room 908 – MSC 4874
Bethesda, MD 20892
Telephone: (301) 435 0793
FAX: 301 480 3661
Email: talbotb@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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 and all copies of the appendix material must be sent to:

Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., Room 1001
Bethesda, MD 20892-4874 (Regular mail)
Bethesda, MD 20817 (FedEx or courier)
Phone: (301) 435-0811

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Center for Research Resources. Incomplete and non-responsive applications will not be reviewed.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The maximum direct costs per award is $150,000. The anticipated size of each award may vary and the actual funding may be less than the levels recommended by the peer review, dependent upon budgetary considerations.

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

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

6. Other Submission Requirements

The NIH recognizes that individual institutions will be positioned to respond in different ways to the opportunities presented in this and the companion CTSA RFA. Applicants may wish to contact NIH Program Staff well in advance of the letter of intent submission date to discuss their possible application. There will be a CTSA Program website at http://www.ncrr.nih.gov/clinicaldiscipline.asp with FAQ's, a Listserv, and a pre-submission National meeting (and videocast) to disseminate information about the CTSA Program. Subscribe to the program Listserv (CTSA-L at http://list.nih.gov) to obtain information about these additional resources. Applicants are invited to arrange a pre-application phone consultation with NIH Program Staff. These contacts will assure that the applicants have a thorough understanding of the intent and expectations of this RFA before they engage in the development of an application.

Specific components for planning that should be addressed include:

1. Focus on clinical and translational science as a discipline. Is there an institutional commitment to developing clinical and translational science as a discipline? Is the proposed range of subject areas broad enough to sustain the program and is this supported and documented by research support and publications of participating faculty? How will the programs be integrated within the institution and the larger community: how will the programmatic experiences be shared and disseminated within the institution, and to the larger community?

2. Research Education, Training and Career Development. Describe how a program to award higher degrees in clinical and translational research will be developed. Indicate whether the graduate school will be located at an affiliated institution and, if so, how program integration will be achieved. Describe any other relevant aspects of research education and career development.

3. Resources and Services. Describe or propose a needs analysis; propose a process to determine expertise, resources, or technologies that the CTSA will develop and offer as a service. The planning process may consider, for example, how to determine and prioritize strategic needs, how to provide resources to multiple types of projects across a wide range of clinical and translational projects and investigators; the strategic scientific importance of the resource; the quality of the science the resource supports; and the quality, cost, and cost-efficiency of the service relative to that of equivalent services from other sources.

4. Location, Organization, Administration, Governance, and Evaluation. Develop plans to develop, organize, administer, and govern an institutional resource that may cross traditional departmental and school boundaries. Where will the CTSA program be placed within the academic institution, and what changes affecting institutional culture or promotion/tenure processes would advance clinical and translational sciences at the institution? Applications involving affiliates or outreach to other institutions should consider how resources are to be made available to these other institutions, means of resolving differences among partnering institutions; plans for continued evaluation and flexibility of the resources that are provided; and processes for billing costs, where appropriate, to investigator grants (chargebacks).

5. Senior Leadership. Explain how senior leadership will be selected. Criteria might include scientific and administrative qualifications; experience and effectiveness; appropriateness of the Program Director's position within the institution; and ability to work across institutional boundaries. Persons from different disciplines and departments or schools within the institution are strongly encouraged.

6. Facilities. Describe how plans will be developed to ensure adequate space and facilities for faculty and researchers participating in the CTSA.

7. Institutional Commitment. Explain the level of resources that participating institutions plan to provide to ensure that the CTSA reaches its full potential, as measured by the adequacy of space, positions, and discretionary funds controlled by the Program Director; oversight of faculty and staff critical to the CTSA; and plans for managing any change in Program Direction.

8. Scientific Quality. Cite overall quality of clinical and translational science, representation of relevant scientific disciplines that maximize productivity, and value added by the proposed CTSA to the research efforts of its members in promoting multidisciplinary clinical and translational research.

9. National Collaboration, Sharing, and Dissemination. Describe a plan to develop intra-institutional and national collaboration, sharing, and dissemination of research and research methodologies.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Center for Research Resources in accordance with the review criteria stated below.

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

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

Significance: What is the vision for the CTSA for which the planning process will be undertaken? Does the proposed planning process have the potential to significantly change the way clinical and translational sciences are pursued at the institution? If the aims of the planning grant are achieved, will this enable the applicant to submit a competitive CTSA application?

Approach: Have the applicants described a robust planning process to develop the integrated components, administration, governance, and evaluation of a CTSA program? Have the applicants indicated how they will plan to address the characteristics of a CTSA program that will create a local and national environment in which clinical and translational science can flourish? Are there integrated plans that provide for multidisciplinary career development opportunities, support for clinical translational sciences, scientific quality, senior leadership, CTSA administration, and organizational capability? Does the applicant acknowledge potential problem areas in the planning process and consider alternative tactics? Does the proposed approach include a plan to span multiple types of clinical and translational research? Is there a plan to ensure that the planning process runs smoothly? Does the management plan ensure that there will be sufficient coordination and collaboration among the members of the planning team?

Innovation: Have the applicants described any innovative approaches that will contribute to the planning process? For example: Does the program challenge existing planning approaches, or address a critical barrier to progress in the field? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies in the planning process that will lead to better design of the final CTSA program? Does the program provide strong evidence that the planning process will provide the institution with vision and clarity that would not otherwise be possible?

Investigators: Are the Principal Investigator, key personnel and planning team appropriately trained and well suited to carry out this planning process? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers?

Environment: Are plans developed to evaluate the scientific, organization, and cultural changes that the applicant institution will need to develop a strong CTSA program? Is there evidence of institutional support for the development of a CTSA?

2.A. Additional Review Criteria:
Not applicable

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed planning activity. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of 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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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 Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Not Applicable

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Dr. Bernard Talbot
Division for Clinical Research Resources
National Center for Research Resources
Room 908 – MSC 4874
6701 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435 0793
FAX: 301 480 3661
Email: talbotb@mail.nih.gov

2. Peer Review Contacts:

Carol Lambert, Ph.D
Office of Review
National Center for Research Resources
Rm. 1076
6701 Democracy Boulevard
Bethesda , MD 20892
Telephone: (301) 435 0814
FAX: 301 480 3660
Email: lambert@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Holly Atherton
Office of Grants Management
National Center for Research Resources
Room Number 1040
6701 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435 0844
FAX: 301 480 3777
Email: athertoh@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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.

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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