In Vivo Cellular and Molecular Imaging Centers (ICMICs) - NCI P50

In Vivo Cellular and Molecular Imaging Centers (ICMICs) - NCI P50 is sponsored by National Cancer Institute (NCI). This program funds 5-year P50 Research Center Grants to support interdisciplinary scientific teams conducting cutting-edge cancer molecular imaging research.

Expired PAR-06-406: In Vivo Cellular and Molecular Imaging Centers (ICMICs)[P50] This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services Participating Organizations National Institutes of Health (NIH), ( http://www.

nih. gov/ ) Components of Participating Organizations National Cancer Institute (NCI), ( http://www. cancer.

gov/ ) Title: In Vivo Cellular and Molecular Imaging Centers (ICMICs)[P50] This is a reissue of PAR-04-069 , which was previously released February 27, 2004. Update: The following update relating to this notice has been issued: April 13, 2009 - This PA has been reissued as (PAR-09-157).

May 11, 2006 (NOT-OD-06-069) - See this notice for Multiple PI Implementation Update Program Announcement (PA) Number: PAR-06-406 Catalog of Federal Domestic Assistance Number(s) 93. 393, 93. 394, 93.

395, 93. 396 Release Date: May 9, 2006 Letters of Intent Receipt Date(s): July 16, 2006; July 16, 2007 Application Receipt Date(s): August 16, 2006; August 16, 2007 AIDS Application Receipt Date(s): N ot applicable Peer Review Date(s): October/November, 2006; October/November, 2007 Council Review Date(s): January / February, 2007; January / February, 2008 Earliest Anticipated Start Date(s): March/April 2007 ; March/April 2008 .

Additional Information To Be Available Date (URL Activation Date): Expiration Date: August 17, 2007 Additional Overview Content The Cancer Imaging Program, Division of Cancer Diagnosis and Treatment, the National Cancer Institute (NCI), solicits applications for new or competing P50 Research Center Grants for In Vivo Cellular and Molecular Imaging Centers (ICMICs). The NCI anticipates awarding two new or competing P50 ICMICs each year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.

Eligible organizations and institutions include: for-profit and non-profit organizations, including public or private institutions; units of local governments; units of State governments; eligible agencies of the Federal government; and domestic institutions/organizations.

Foreign institutions and organizations may participate only as collaborators or subcontractors (and are therefore not eligible to submit applications in connection with this PAR). Any individual with the skills, knowledge, and resources necessary to execute the functions proposed for the ICMIC is invited to work with his/her institution to develop an ap plication for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one Principal Investigator (PI), or multiple PIs, may be designated on the application. An institution may submit only one application and may have only one funded ICMIC.

Applications must be prepared using the PHS 398 research grant application and forms. Application materials are available from the NIH Office of Extramural Research (OER) at http://grants. nih.

gov/grants/oer. htm . Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information 1.

Mechanism(s) of Support Section III. Eligibility Information 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 B.

Sending an Application to the NIH C. Application Processing 4. Intergovernmental Review 6.

Other Submission Requirements Section V. Application Review Information 2. Review and Selection Process A.

Additional Review Criteria B. Additional Review Considerations D. Sharing Research Resources 3.

Anticipated Announcement and Award Dates Section VI. Award Administration Information 2. Administrative and National Policy Requirements 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 The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the progress in molecular imaging as the basis for the extraordinary, non-invasive and quantitative analytical tools useful in the diagnosis and treatment of cancer as well as in the laboratory environment to interrogate biological pathways relevant to cancer.

The Cancer Imaging Program of the NCI solicits new or competing applications for P50 Research Center Grants for In Vivo Cellular and Molecular Imaging Centers (ICMICs). The program will fund the 5-year P50 ICMIC grants to support interdisciplinary scientific teams conducting cutting-edge cancer molecular imaging research with clinical relevance.

ICMIC funding is designed to: (1) support unique core facilities; (2) enable the awardees to initiate pilot research in new promising directions; and (3) provide interdisciplinary career development opportunities for investigators new to the field of molecular cancer imaging.

The P50 funding mechanism and the intended ICMIC structure promote integration of resources and expertise to facilitate synergistic and creative scientific interactions, while allowing each center to define research objectives that would maximize individual unique scientific strengths of each research team.

Collectively, the formation of multidisciplinary ICMICs is expected to stimulate cancer imaging research and streamline the implementation of the imaging technologies in patient care. Molecular imaging now has an impact on every aspect of clinical cancer management, both directly and indirectly.

Examples of direct clinical applications include, but are not limited to, the continued development and testing of targeted molecular imaging agents for the detection and diagnosis of cancer as well as for guiding and monitoring therapeutic interventions. There is also an increasing demand for pre-clinical molecular imaging tools.

These pre-clinical tools include, but are not limited to, model systems for the discovery and in vivo testing of novel cancer therapeutics and systems to validate emerging biomarkers. Even though these tools will not be intended for direct use in the clinic, they are expected to have a definite positive impact on the availability of new and more efficacious treatments in the clinic.

Since the initiation of the ICMIC Program in 1999, the field of molecular imaging has made significant and rapid advances. The formation of multidisciplinary research teams has stimulated and streamlined cancer imaging research from inception to use in patient care.

The flexibility of the P50 ICMIC structure allows each Institution to capitalize on its own unique scientific strengths, and to define the structure and research objectives that create the most synergistic and creative scientific interactions. In general, an ICMIC will provide researchers with the following critical resources. Special Features and Research Objectives of the ICMIC Program 1.

Multidisciplinary Expertise of ICMIC Team s. The ICMICs will provide an organizational structure specifically designed to facilitate multi-disciplinary interactions among investigators focused on the ultimate goal of discovering, developing, and translating molecular imaging technologies that will have eventual impact in the clinic.

The structure of the ICMIC is designed to provide investigators with the means of conducting multidisciplinary research in a highly collaborative atmosphere and consistent access to expertise, with minimal wasted time and effort.

Key personnel of ICMICs may comprise scientists from a variety of fields including, but not limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cell and molecular biology, pathology, pharmacology, computational sciences, and biomedical engineering. Other specialists, for example in fields such as MRI physics, immunology, or neuroscience, may also be involved.

Most importantly, ICMIC personnel must demonstrate an eagerness to collaborate outside of their own disciplines. The nature of these interactions will be determined by the applicants, and emphasis will be placed on establishing creative, productive, and synergistic interactions with eventual clinical impact. 2.

Research Components. The ICMICs will provide funding for a minimum of three Research Components. Research Components will apply multidisciplinary approaches based on molecular imaging that are either: (a) directly applicable to the clinic; or (b) reflect the pre-clinical development of molecular imaging reagents or technologies that will ultimately support clinically-relevant research.

Individual research projects will be structured in order to maximize appropriate scientific interactions between the projects, and coordinated utilization of the Specialized Resources (see below). Each Research Component will be similar in size and scope to a typical R01 or subproject of a P01, and will be expected to meet the same standards of preliminary data in support of the hypotheses. 3.

Specialized Resources. The ICMICs will provide Specialized Resource Facilities and Services. The lack of available facilities for cross-disciplinary experiments is often a barrier to productive scientific interactions.

Demands on equipment, resources, and reagents in every scientific area are extremely high, and this demand prohibits ready access to investigators interested in expanding their studies into new areas of research. The establishment of Specialized Resources dedicated to ICMIC-related research will enable this access.

The Specialized Resource(s) will be determined by the requirements of the Institution, the defined scientific goals of the Research Components of the ICMIC, and budgetary limits. Prioritization of the research projects supported through ICMIC Specialized Resources will be an essential function of the ICMIC’s leadership, and the mechanism to be employed for prioritization must be delineated by the applicants.

Resource facilities may be utilized by active members of the ICMIC and will also be available to investigators supported through Developmental Funds (see below). 4 . Developmental Funds for Pilot Projects.

ICMICs will provide Developmental Funds for feasibility testing of new projects. A high priority of each ICMIC will be the solicitation and selection for support of innovative pilot projects that would stimulate interdisciplinary collaborations, while addressing promising emerging research opportunities. The selection of projects will be through a review process established by the ICMIC’s leadership.

This fund is not to be used to support traditional, ongoing projects that could readily be supported through R01s; it is not appropriate for projects that utilize single areas of expertise or to support the continuation of previously funded research projects. Developmental Projects may not be supported for more than 2 years. Necessary equipment should be provided through the appropriate Specialized Resource.

These projects are to be monitored closely by the ICMIC leadership. Investigators working on projects supported through the Development Fund must understand that they will be expected to compete for independent R01 funding when the projects become sufficiently mature. Alternatively, if it becomes obvious that the project will not provide the expected results, a plan should be in place for terminating a development project.

5. Career Development Opportunities. ICMICs will provide career development opportunities for new and established investigators.

Current graduate programs are generally focused on single disciplines and may be inadequate to train the needed cadre of inter-disciplinary imaging scientists. The ICMICs will provide support for a limited number of pre-and post-doctoral trainees in a program to be defined by the applicants. Career development opportunities through the ICMIC will be expected to be highly cross-disciplinary.

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 P50 award mechanism. As an applicant, you 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 (additional instructions below). The NCI anticipates awarding two new or competing P50 ICMICs each year.

The total project period for a P50 application submitted in response to this PAR may not exceed 5 years. Based on the past awards, each of the two projected ICMIC awards are anticipated to amount to approximately $1,800,000-$2,000,000 total costs per year. The total costs requested (direct costs plus Facilities and Administrative costs) for a new or competing renewal P50 ICMIC application may not exceed a maximum of $2,000,000 per year.

Applications that exceed a total cost of $2,000,000 per year will be returned to the investigator as non-responsive to the PAR. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the NCI 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.

A.

Eligible Institutions You may submit (an) application(s) if your organization has any of the following characteristics: For-profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals, and laboratories; Units of State governments; Units of local governments; Eligible agencies of the Federal government; and Foreign institutions and organizations may participate only as collaborators or subcontractors (and are therefore not eligible to submit applications in connection with this FOA).

1. B. Eligible Individuals Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support.

Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PI, or multiple PIs, may be designated on the application. Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research awards can be found at http://grants.

nih. gov/grants/multi_pi . All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.

nih. gov/ElectronicReceipt/preparing. htm for instructions).

The decision of whether to apply for a single PI or multiple PI grant is the responsibility of the applicant organization and should be determined by the scientific goals of the project. Applications for multiple PI grants will require additional information, as outlined in the instructions below, and the NIH review criteria for approach, investigator and environment will be modified as indicated below.

For example, a weak or inappropriate PI can have a negative effect on the review. If the multiple PI grant option is elected, a contact PI must be named, as described in the instructions below. Multiple principal investigators on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.

Each principal investigator is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. Multiple PIs may be located at the same institution or at different institutions and may request budget apportionment between the PIs (see supplementary instructions below).

For multiple organizations, a subcontract or consortium arrangement must be agreed on by the participating organizations, as described in special instructions below. 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 An institution may only have one funded ICMIC. Section IV.

Application and Submission Information 1. Address to Request Application Information The PHS 398 application instructions are available at http://grants. nih.

gov/grants/funding/phs398/phs398. html in an interactive format. Applicants must use the currently approved version of the PHS 398.

For further assistance, contact GrantsInfo; Telephone: (301) 710-0267, Email: [email protected] . Telecommunications for the hearing impaired: TTY 301-451-5936. 2.

Content and Form of Application Submission Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.

dnb. com/us/ . The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS: 1) Inclusion of Multiple PIs (if appropriate): Face page.

Name of Principal Investigator (PI) The PI is the individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically.

Each PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating institution, for the proper conduct of the project or program, including submission of all required reports. When multiple PIs are proposed, use Face Page (Continued) page to provide items 3a-3h for all PIs. NIH requires one PI be designated as the contact PI for all communications between the PIs and the agency.

The contact PI must meet the eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PI may be changed during the project period. The contact PI should be listed in block 3 of Form Page 1 (the Face Page), with additional PIs listed on the Face Page (Continued).

All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era. nih. gov/ElectronicReceipt/preparing.

htm for instructions). Format Page 2. Key Personnel When multiple PIs are proposed, list the Contact PI first, then all additional PIs in alphabetical order.

Then, list all Key Personnel, giving name and organization. The budget(s) should be presented in logical, discrete units for each section of the application using the standard PHS-398 form pages 4-5.

The budgets to be submitted should include: a) A detailed composite budget for the entire ICMIC; b) A separate budget for Administrative and Organizational activities; c) A separate budget for each individual Research Component; d) A separate budget for each Specialized Resource; e) A single separate budget section for the Developmental Component; and f) A single separate budget for the Career Development Component.

Additional pages for budget justification are to be used when necessary. The following format is suggested for completing the Research Plan section (see pages 19 through 23 of the PHS 398 application brochure.) The application should be as concise as possible to ensure a thorough review.

a) ICMIC Description (not to exceed 10 pages) This section should be used to present the overall vision for the ICMIC. This summary should contain the long and short-term scientific objectives, specifically addressing how the molecular imaging research supported through the ICMIC will impact clinical cancer care.

Summarize the organizational structure for the ICMIC, concisely defining Research Components, Specialized Resources, the Developmental Fund, and the Career Development Component, and their relationships to each other.

In addition, relationships between the ICMIC and other research, academic, and administrative units of the institution(s) (such as centers, institutes, departments) and the central administration should be described in this section. The ICMIC description should serve as an overview of the ICMIC, with a more detailed description of each component to be presented in a later section.

Competing applications should include a progress report for the previous funding period. Specifically address any significant scientific changes, including addition/deletion of Research Components or Specialized Resources. Revised applications may include a 1-page introductory statement addressing concerns of the previous review.

b) Organization and Administration (not to exceed 20 pages, including any organizational charts). A separate budget should be prepared and included for centralized administrative and organizational activities. The Organizational and Administrative Component should describe all of the infrastructure and decision-making needs of the ICMIC.

Appropriate for inclusion in this component would be (not necessarily in the following order): description of the role(s) and responsibilities of lead investigators, internal and external advisory committees as well as participating investigators; description of decision-making and oversight responsibilities for each Research Component; description of decision-making, oversight responsibilities and anticipated utilization for each Specialized Resource; description of how existing resources (if available and applicable) are to be utilized by the ICMIC, stating explicitly how they differ from new Specialized Resources to be established as a part of the ICMIC and what arrangements have been made to ensure access by ICMIC Investigators to those existing resources; description of decision-making and oversight responsibilities for the Developmental Fund, including the process for selecting, monitoring, and terminating the Developmental Projects; description of decision-making and oversight responsibilities for the Career Development Component, including the process for selecting, monitoring, and terminating trainees; description of ICMIC-sponsored activities designed to foster multidisciplinary interactions, such as regularly scheduled forums for the presentation and discussion of multidisciplinary research topics; detailed description of Institutional commitment to the ICMIC; and description(s) of commitment(s) to interact with other ICMICs, including inter-ICMIC meetings.

Competing applications should include a progress report for the previous funding period. Specifically address any significant organizational changes. Include relevant information about oversight committee activities during the previous funding period, and their impact on the functioning of the ICMIC and provide summaries of the activities of the Developmental Project and Career Development Programs.

Revised applications may include a 2-page introductory statement addressing concerns of the previous review. c) Research Components (not to exceed 25 pages each) Research Components will define the scientific projects supporting the long-term goals of the ICMIC, and are to be presented using the format of a traditional research project [Research Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)].

The leader(s) of each Research Component will be responsible for ensuring that ongoing research project(s) are relevant to the ICMIC goals, and that the investigators and projects remain highly integrated with other ongoing ICMIC research. Research Components may rely on the support of the Specialized Resources.

To ensure a sufficient level of multidisciplinary interaction, no fewer than three Research Components should be included in the application; the maximum number will be determined by the identified needs of the investigators and budgetary constraints. The total number of pages for each Research Component is not to exceed 25.

Describe each Research Component in sufficient detail to enable reviewers to judge the scientific merit from the written application. Do not present separate "subprojects." All projects are to have a single theme and budget.

More than one PI, or multiple PIs, may be designated on each Research Component (see Eligibility Criteria [above] and Review Criteria [below]). If a Research Component PI is not a PI for the ICMIC application, he/she should be listed on the Key Personnel page as a Research Component PI with the name of the component provided. Research Component PIs should not be listed on the Principal Investigator expansion page.

The Leadership Plan (Section I) for the ICMIC application should address the governance and organizational structure for Research Components with more than one PI.

Following the description of the scientific goals, each Research Component should summarize exactly how the project integrates with the goals of the ICMIC, how it will directly support or impact clinical cancer care, how it will communicate and complement the other Research Components, and how it will utilize the Specialized Resources.

Describe in this section the relevance of the project to the primary theme of the ICMIC and the collaborations with investigators within the ICMIC. Explicitly state which Specialized Resources will be used by this Research Component, and, if possible, quantitate the anticipated usage of Specialized Resources in tabular format.

This summary should not exceed 1-2 pages, which are included in the 25-page limit for each Research Component section. Competing applications must provide a Progress Report on the previously funded Research Component (Section C). Summarize the previous application’s specific aims and the importance of the findings.

Discuss any changes in the specific aims as a result of advances in the field of molecular imaging. Include the complete references to appropriate publications and manuscripts accepted for publication (not part of the page limitations). For all new projects, include justification of how this Research Component contributes to the overall ICMIC scientific vision.

Revised applications may include a 3-page introductory statement addressing concerns of the previous review. d) Specialized Resources (not to exceed 15 pages each) Specialized Resources may include laboratory and clinical facilities, equipment, and services. For each Specialized Resource, describe in detail the resource(s) that it will provide to the ICMIC.

In addition, describe its role in the overall functioning of the ICMIC, including how each resource will enhance multidisciplinary research, and a description of the projects that will be supported by the Specialized Resource. 1. Using a Form PHS 398 Continuation Page, denote "Specialized Resource" and the Specialized Resource director's name.

If there is to be more than one core component, prepare a separate section for each core (i.e., Specialized Resource A, Specialized Resource B, etc.). 2. For each Specialized Resource, describe the role of the Specialized Resource as a core to the ICMIC as a whole.

Clearly present the facilities, resources, services, and professional skills that the core component provides. 3. To aid in the review, it is suggested that a table to show the estimated or actual proportional use of this Specialized Resource by each project, be included in the application.

Justify this core component by discussing ways in which these centralized services improve quality control, produce an economy of effort, and/or save overall costs compared to their inclusion as part of each project in the P50 ICMIC. Competing applications must provide a Progress Report on the previously funded Specialized Resource.

Summarize the activities of the previous Specialized Resource specifically in relation to the services and resources provided to the funded Research Components and Developmental Projects and describe the importance of the findings. Discuss any planned changes in the resource as a result of advances in the field of molecular imaging.

For all new Specialized Resources, include justification of how it will contribute to the overall ICMIC scientific vision. Revised applications may include a 3-page introductory statement addressing concerns of the previous review.

e) Developmental Fund (not to exceed 20 pages) This section should include a description of the Developmental Project(s) that will be initiated during the first year of ICMIC funding, including a summary of which Specialized Resources will support the projects, and to what level that support will occur.

The description of decision-making and oversight responsibilities, including the process for selecting, monitoring, and terminating the Developmental Projects should be included in the "Organization and Administration" Section of the application. This section should include only the scientific portion of the Developmental Projects.

The Developmental Projects should provide an avenue for introducing and integrating new investigators and innovative technologies and/or methodologies into the ICMIC infrastructure (in specific) and molecular imaging (in general). It should not be viewed as a supplemental source of funding for investigators that are already integrally invested in the success of the ICMIC.

Since the Developmental Projects will be flexible, only the first year of projects should be included in the application. However, applicants should include in their budgets appropriate funds to also support Developmental Projects in years 2-5 of the award.

The Developmental Fund projects must be multidisciplinary, and each is to be presented using the format of a traditional research project [Research Plan: Include Sections a-d (Instructions for PHS 398, Pages 15-17)]. The number of Developmental Projects to be initiated will be determined by the ICMIC applicants.

Competing applications must provide a concise Progress Report on the Developmental Projects selected in the previous funding period. For each Developmental Project include title, description, Principal Investigator, summary of results and outcomes (5 additional pages are allowed for this Progress Report). Revised applications may include a 3-page introductory statement addressing concerns of the previous review.

f) Career Development Component (not to exceed 15 pages) Career Development opportunities sponsored by ICMICs will provide a limited number of trainees with access to a highly cross-disciplinary experience. The extent of the Career Development Component is to be defined by the applicant, based on the needs and capabilities of the ICMIC participants.

Applicants for career development support may be new investigators or established investigators who wish to change research directions. Candidates should be scientists who have demonstrated outstanding research potential but who need additional time in a productive scientific environment to establish an independent, multidisciplinary research program. Recruitment must include qualified women and minorities.

To this end, each applicant should propose a clear policy and plan for recruitment of career development candidates. The ICMIC application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process.

Also, the application should indicate prospective mentors who are already in place at the proposed ICMIC, briefly describe their research programs, and describe complementary activities that contribute to the environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs).

Competing applications must provide a concise Progress Report on the activities of each investigator selected for funding through the Career Development Component. For each investigator, include title, description, Principal Investigator, summary of results and outcomes. (Five additional pages are allowed for this Progress Report.)

Revised applications may include a 3-page introductory statement addressing concerns of the previous review. 4) Section I. Multiple PI Leadership Plan.

For applications designating multiple PIs, a new section titled Leadership Plan should be included. The governance and organizational structure of the overall research project (ICMIC) should be described, including communication plans, publications, intellectual property issues, and procedures for resolving conflicts.

The roles and shared administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs, including responsibilities for human subjects and animal studies as appropriate. For competing continuation applications, the application should state how the research will be enhanced by employing a multiple PI approach.

This section should also address the governance and organizational structure for Research Components that have designated more than one PI. 5. Section J.

Consortium/Contractual Arrangements: If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required. 3. Submission Dates and Times See Section IV.

3. A for details. 3.

A. Receipt, Review, and Anticipated Start Dates Letters of Intent Receipt Date(s): July 16, 2006; July 16, 2007 Application Receipt Date(s): August 16, 2006; August 16, 2007 Peer Review Date(s): October/November, 2006; October/November, 2007 Council Review Date(s): January / February, 2007; January / February, 2008 Earliest Anticipated Start Date(s): March/April