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)

Announcement Type
This is a reissue of PAR-06-406

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-09-157

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396

Key Dates
Release/Posted Date: April 13, 2009
Letters of Intent Receipt Date(s): September 28, 2009; September 28, 2010; September 28, 2011
Application Due Date(s): October 28, 2009; October 28, 2010; October 28, 2011
Peer Review Date(s): March 2010; March 2011; March 2012
Council Review Date(s): May 2010; May 2011; May 2012
Earliest Anticipated Start Date: July 2010; July 2011; July 2012
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: (Now Expired August 25, 2011 per NOT-CA-11-021), Original Date: October 29, 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 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 and Information

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

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

The Cancer Imaging Program, and the Division of Cancer Diagnosis and Treatment, at the National Cancer Institute (NCI), invite new or renewal (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. ICMIC funding is designed to: (1) support innovative cancer molecular imaging research projects; (2) support unique core facilities; (3) enable the awardees to initiate pilot research in new promising directions; and (4) provide interdisciplinary career development opportunities for investigators new to the field of molecular cancer imaging.

Background

In vivo cancer molecular imaging is now essential to the rapid advances in cancer biology and clinical oncology. It is critical to maintain the development of novel imaging agents and technologies in order to keep pace with changes in experimental laboratory and clinical approaches for the diagnosis and treatment of cancer. Systems-wide interrogations of the molecular and cellular pathways associated with cancer will require innovative imaging solutions that can only be developed in a highly multidisciplinary environment. The involvement of clinician scientists in all aspects of ICMIC-supported research will ensure that opportunities arising from discoveries made within the basic research arena will be identified and rapidly applied to the clinic. The flexibility associated with the ICMIC structure is ideally suited to establishing and maintaining these highly multidisciplinary environments.

Special Features and Research Objectives of the ICMIC Program

1. Multidisciplinary Expertise of ICMIC Teams. 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. 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.

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. 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 to provide 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 of Support

This funding opportunity will use the NIH specialized center (P50) grant mechanism.

The applicant 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).

2. Funds Available

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.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Non-Domestic (i.e., Foreign) organizations are NOT eligible for application submission but may participate (under subcontractual arrangements) in collaboration with an eligible Domestic applicant institution.

1.B. Eligible Individuals

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

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

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

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

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and renewal applications will be permitted only a single amendment (A1). Original new and renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Applicants may submit renewal applications.

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

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: 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

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

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

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

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

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 28, 2009; September 28, 2010; September 28, 2011
Application Due Date(s): October 28, 2009; October 28, 2010; October 28, 2011
Peer Review Date(s): March 2010; March 2011; March 2012
Council Review Date(s): May 2010; May 2011; May 2012
Earliest Anticipated Start Date: July 2010; July 2011; July 2012

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Anne E. Menkens, Ph.D.
Cancer Imaging Program
National Cancer Institute (NCI)
6130 Executive Boulevard, EPN Room 6068
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9531
Fax: (301) 480-3507
Email: am187k@nih.gov

3.B. Sending an Application to the NIH

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

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-3428
Email: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

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

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

6. Other Submission Requirements and Information

Budget for ICMIC Workshop: ICMIC investigators will be expected to participate in ICMIC workshops and investigator meetings as necessary to share results with other ICMICs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations. Travel funds for the Principal Investigator(s) and selected ICMIC investigators and collaborators should be budgeted for this purpose.

Projects that Involve Clinical Trials: For those projects that involve clinical trials, investigators must include a general description of the Data and Safety Monitoring Plan (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) in the application. All clinical trials supported or performed by NIH require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the Principal Investigator/project manager or NIH program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the Data and Safety Monitoring of Clinical Trials see, http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.

Research Plan Page Limitations

The page limit of 12 pages for Item 3 of the Research Plan, as stated in the PHS Form 398 instructions, applies to each core and research project, except the Career Development component, which has a page limit of 25 pages.

INSTRUCTIONS FOR PREPARATION OF ICMIC APPLICATIONS:

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.

2) Table of Contents.

3) Budget(s).

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.

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 renewal 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) Research Plans for each project and core.

The following format is suggested for completing the Research Plan section (see the PHS 398 application brochure.) The application should be as concise as possible to ensure a thorough review.

Please precede each component with a Description (Abstract), using PHS 398 Form.

A) Overall Research Strategy

1) ICMIC Description (not to exceed 12 pages - resubmission applications may also include an additional 1-page introductory statement addressing concerns of the previous review). This section should be used to present the overall vision for the ICMIC. This summary should contain the long and short-term scientific objectives. 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.

Renewal applications (formerly known as 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.

2) Organization and Administration (not to exceed 12 pages, including any organizational charts - Resubmission applications may also include an additional 2-page introductory statement addressing concerns of the previous review.). A separate budget should be prepared and included for centralized administrative and organizational activities. The Organizational and Administrative Component should describe how all of the infrastructure and decision-making needs of the ICMIC will be met.

Appropriate for inclusion in this component would be (not necessarily in the following order):

B) Research Component Projects (not to exceed 12 pages for the Research Strategy for each project - Resubmission applications may also include an additional 1-page introductory statement addressing concerns of the previous review).

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]. 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 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 12-page limit for each Research Component section.

Renewal 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.

C) Specialized Resources (not to exceed 12 pages each - Resubmission applications may also include an additional 1-page introductory statement addressing concerns of the previous review)

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.

Renewal 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.

D) Developmental Fund Projects (not to exceed 12 pages for each Research Strategy). 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]. The number of Developmental Projects to be initiated will be determined by the ICMIC applicants.

Renewal 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 (no additional pages are allowed for this Progress Report).

Resubmission applications may include a 1-page introductory statement addressing concerns of the previous review.

E) Career Development Component (not to exceed 25 pages for each project- Resubmission applications may also include an additional 1-page introductory statement addressing concerns of the previous review).

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. In addition, 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).

Renewal 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. (Three additional pages are allowed for this Progress Report in addition to the 25 page limit.)

Resubmission applications may include a 3-page introductory statement addressing concerns of the previous review.

6) 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.

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

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

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

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

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

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by appropriate peer review groups convened by the National Cancer Institute (NCI) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

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

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

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

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

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

In addition to the standard NIH criteria, the following criteria will be used to evaluate P50 ICMIC-specific components/aspects of the application. Where indicated, reviewers and discussants will assess ICMIC components based on each of five core review criteria (Significance, Investigator(s), Innovation, Approach, and Environment). A given component does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a component that by its nature is not innovative may be essential to advance a field.

1) ICMIC as an Overall Program

2) Organization and Administration

2) Research Components

The five criteria Core Criteria (Significance, Approach, Innovation, Investigators, and Environment) are to be used to evaluate individual Research Components in ICMIC applications. In addition to those five Core Criteria, the following criteria are to be addressed

2) Specialized Resources

3) Developmental Projects

The Developmental Projects will be reviewed as a cluster , reflecting the cumulative scientific strength of the projects and the process, rather than assigning each project an independent merit rating.

4) Career Development Program

The initial review group will also examine the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment.

Additional Review Criteria

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

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

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

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

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

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Additional Review Considerations

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

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

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

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

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

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.

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.

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 12 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.

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).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

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:

Anne E. Menkens, Ph.D.
Cancer Imaging Program
National Cancer Institute (NCI)
6130 Executive Boulevard, EPN Room 6068
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9531
Fax: (301) 480-3507
Email: am187k@nih.gov

2. Peer Review Contacts:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8040, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Eileen M. Natoli
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8791
Fax: (301) 496-8601
Email: Natolie@gab.nci.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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/

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.

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.

Inclusion of Women, Minorities, and Children:
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 FOA, 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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