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/
National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov/

Title: Tumor Microenvironment Network (TMEN) (U54)

Announcement Type

Reissuance of RFA-CA-06-014

Request For Applications (RFA) Number:   RFA-CA-10-021

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.397, 93.399, 93.398

Key Dates
Release Date: September 30, 2010
Letters of Intent Receipt Date: December 20, 2010
Application Receipt Date: January 20, 2011
Peer Review Date: May/June 2011
Council Review Date: August 2011
Earliest Anticipated Start Date: September 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 21, 2011

Due Dates for E.O. 12372

Not Applicable.

Pre-application Informational Teleconference for Potential Applicants

The NCI is planning to have a pre-application informational teleconference approximately two months before application receipt deadline. An announcement indicating the date and time of the informational teleconference will be posted on the website of the Division of Cancer Biology, NCI (http://dcb.nci.nih.gov).

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, Review and Anticipated Start Dates
 1. Letter of Intent
 B. Sending an Application to the NIH
 C. Application Processing
 D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI) and the National Institute of Neurological Disorders and Stroke (NINDS), solicits applications for multidisciplinary Research Centers focused on the tumor microenvironment. The Centers will form the NCI Tumor Microenvironment Network (TMEN, also referred to as the “Network”). Through use of the NIH U54 cooperative agreement mechanism, this FOA will support up to 10-11 individual TMEN Research Centers.

The main objective of the TMEN initiative is to delineate mechanisms of tumor-stroma interactions in human cancer. Such an effort is likely to generate a more comprehensive understanding of the composition(s) of the stroma in normal tissues as well as of the role(s) of the stroma in tumor initiation, progression, and metastasis as well as in responses to treatment.

TMEN Research Centers are designed to pursue defined, individual research programs (consisting of related projects, to be proposed in the applications) as well as engage in cross-network activities and joint projects with other TMEN teams. To facilitate multidisciplinary approaches, prospective applicants are encouraged to consider teams with broad areas of expertise. Expertise in specific tumor site(s) is desirable, as the emphasis is on using human tissues, complemented, as appropriate, by experimental models.

TMEN Research Centers are envisioned to engage in various collaborative activities within the Network. TMEN infrastructure is expected to establish repositories of critical reagents, resources, and information as well as promote and facilitate interdisciplinary collaborations both within and outside the Network.

Even though this FOA builds on the success of the previous TMEN Program, it is intended to explore new scientific opportunities and themes that have emerged recently. Therefore, this FOA is open to all qualified investigators and all applications will be reviewed as new applications (including those from current TMEN awardees).

Non-responsive to this FOA:

Background

Several well established lines of evidence point to the roles of the environment in tumorigenesis: (a) tumors, like organs, are composed of a variety of interdependent cell types, matrices, microbiomes, and soluble factors that affect tumor development and metastasis; (b) the interactions between a tumor and its microenvironment occur at the earliest onset of disease, and are dynamic and bidirectional; (c) progression of cancer depends on the co-evolution of tumor cells with other cells in their immediate or circulating microenvironments; and (d) tumor stroma can contribute to inefficient drug delivery, drug resistance, and morbidity. Accordingly, a better understanding of the tumor microenvironment is likely to have a profound and immediate impact on therapeutic intervention as well as biomarkers for cancer detection and prognostic evaluation. Indeed, some of the recent discoveries are already being applied translationally in cancer diagnostic and therapeutic trials. However, the mechanisms by which the microenvironment may facilitate early cancer initiation and cancer progression still are not fully understood.

In the past several years, studies on tumor-host interactions have provided significant insights into the role of tumor stroma in tumor cell migration, invasion, angiogenesis, inflammation, and progression. Many of the areas of research proposed in this FOA are new directions that have emerged from the new knowledge gained and indicate that the tumor stroma has the potential to be exploited as a novel therapeutic target. A new appreciation of the role of stroma in cancer initiation, progression, and metastasis, as well as in responses to treatment has led to the notion that the tumor microenvironment is one of the most critical modulators of tumor phenotype. In this context, the areas for scientific exploration include: functional relevance of tumor-associated stroma in tumor progression, metastasis, and responses to treatment; emerging roles of microbiome and aberrant metabolism in tumor progression; and functional relevance of gradients and soluble factors in the tumor microenvironment. Potential fundamental as well as practical benefits warrant vigorous efforts to advance these important fields of studies.

General Research Objectives and Requirements

A. Overall TMEN Goals

The overall TMEN focus is on the dynamic complexity of tumor-host interactions in different organ systems. Two specific overall goals are: 1) to encourage fundamental research aimed at a comprehensive understanding of the composition(s) of the stroma in normal and cancer human tissues, as well as of the role(s) of the stroma in tumor initiation, progression, and metastasis, and responses to treatment; and 2) to foster and facilitate research in this area by developing, and making available to the research community, necessary resources and infrastructure. Scientific goals for individual TMEN Research Centers are outlined below.

In addition, TMEN is expected to interact with related NCI Programs [e.g., the Integrated Cancer Biology Program (http://icbp.nci.nih.gov) and the Mouse Models of Human Cancer Consortium (http://mmhcc.nci.nih.gov)]. The NCI will facilitate these inter-program interactions to maximize integrative perspective in research on the tumor microenvironment.

B. Scientific Goals for Individual Research Programs at TMEN Research Centers:

TMEN Research Center applicants are expected to focus their research programs on tumor-host interactions as critical components of the tumor initiation, progression, and metastatic cascade as well as the role of tumor-stroma interactions in responses to treatment.

Applications responsive to the initiative are expected to focus on human tumors, complemented as appropriate with animal models. However, applications relying solely on animal models are not responsive.

Areas of research emphasis. All TMEN Research Center applicants are expected to address one or more of the major areas of emphasis listed below. To achieve the broad goal of characterizing the tumor microenvironment and its interactions with the tumor, the proposed research programs may include (but are not limited to) the following areas.

General and NCI-specific Areas of Emphasis:

NINDS-specific Focus:

In addition to the listed above general and NCI-specific areas of emphasis, NINDS is particularly interested in research programs relevant to:

NINDS will only consider support of primary central nervous system and peripheral nervous system (CNS/PNS) tumor applications. Other tumor sites (e.g., breast, lung, prostate, colon, etc.) or secondary brain tumors (i.e., metastases to the brain) activities, which are relevant to the NCI priorities, are not considered relevant to the mission of NINDS.

C. Team Capabilities. Each applicant group should provide evidence of on-going relevant research and institutional resources that augment and sustain the research strengths of the team. Applicant institutions are encouraged to commit additional dedicated resources in support of any group from their institution that is responding to this funding opportunity announcement. Applicants are encouraged to seek partners or collaborators from the for-profit private sector where their participation is appropriate. In structuring these partnerships or collaborations, applicants should take into account pre-existing intellectual property rights associated with the use of existing models/reagents and make appropriate licensing arrangements. Applicants and their technology licensing offices are encouraged to seek assistance as needed from the NCI Technology Transfer Branch (http://www-otd.nci.nih.gov/) in determining whether such arrangements are appropriate and/or adequate.

Collaborations and other resources: In assembling their teams, applicants are encouraged to consider the availability of research expertise, technologic innovations, and potential collaborations from existing NIH-funded networks and programs, including, in particular, the NCI-funded programs listed below:

Studies using human tumor samples as well as whole animal models are expected to need a variety of imaging technologies for visualizing the components of the stroma at the levels of individual cells and molecules. These technologies include, but are not limited to: multiphoton and deconvolution microscopy; selection of live cells from tumors; stromal markers; 3D matrix reconstitution; and organotypic models. Collaborations with engineers, physicists, and imaging biologists who can apply the most current imaging technologies to studies of normal and tumor microenvironments in experimental models or in human cancers are encouraged. Interaction with systems biologists and bioengineers to generate a comprehensive picture of “tumors as complex organs” through the understanding of the multiple complex signaling pathways within and between tumor, stromal cells, the extracellular matrix as well as other soluble factors during tumor initiation, progression, metastasis, and cancer therapies is also encouraged.

D. Leadership and Coordination of Research Centers (Administrative Core).

Applicants proposing TMEN Research Centers are expected to have well thought-out plans and appropriate leadership structure for organizing and coordinating multiple projects, incorporating diverse, multidisciplinary approaches, recruiting and training personnel, and coordinating trans-Network activities. To facilitate these activities, each proposed TMEN Research Center must organize a dedicated Administrative Core (for details, see Section IV.6. Other Submission Requirements).

After the award has been issued, each TMEN Research Center must also form an External Advisory Panel (EAP) to include three to five experts in the areas currently being addressed within the Program.

E. Trans-Network Activities

As a part of joint Network activities, TMEN awardees will be charged with developing resources for the community, and TMEN-sponsored outreach activities will be a significant part of TMEN. This will require interaction and collaboration among TMEN-funded investigators and/or with other investigators. Examples of these activities include: (a) generation of critical reagents, models, technologies, and related resources that can advance the field; (b) dissemination of the TMEN-generated resources to the cancer research community at-large; (c) participation of junior investigators (postdoctoral fellows and graduate students) in biannual TMEN meetings; and (d) other outreach and educational activities, e.g., cross-training of the postdoctoral and graduate students in newly-funded TMEN PIs’ laboratories for learning new technologies, assays, imaging techniques, and co-culture models.

Through the Network, the individual Research Centers and thereby the investigators, will have access to resources, information, technologies, ideas, and expertise that are beyond the scope of any single research team. While each funded Research Center will be largely self-sufficient, investigators will be expected to devote a portion of their effort to participating in collaborative activities with other Network members to improve existing technologies in the field, develop novel reagents, and disseminate information to the research community at-large. Additional support for these activities will be made available by the NCI as appropriate. Examples of such collaborative activities include the development of reagents, assays, technologies, and experimental models to study tumor-stroma interactions.

The Network will: provide an appropriate venue for close interactions among investigators; facilitate frequent exchange of data and comparison of results obtained across a variety of tumors; and disseminate expertise that may be initially concentrated within a single Research Center.

The NCI will ensure common access to Network-generated resources and reagents for broader cancer research community. Once TMEN is established, the NCI will also encourage the Network members to interact with existing NCI-supported multidisciplinary groups, such as the Early Detection Research Network, the Mouse Models of Human Cancer Network, and the Integrated Cancer Biology Program.

To facilitate communications among the participants in the TMEN and between the TMEN and the NCI, the NCI will establish and maintain an Internet-based information technology solution for rapid data and document transmission and electronic communications for the TMEN.

TMEN Governing Structure: Individual TMEN Research Centers will operate independently but under a common Steering Committee as a governing body. For details on the organization and tasks of TMEN Steering Committee, see Section VI.2.A. Terms and Conditions of Cooperative Agreement.

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

Section II. Award Information


1. Mechanism of Support

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

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

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

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, the NCI anticipates that the size of each award may also vary.

Although the financial plans of the NCI and NINDS provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications meeting the programmatic priorities of the NCI and NINDS.

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:

NOTE: Foreign institutions are NOT eligible to apply. Investigators from Foreign institutions may participate as a component of an application submitted by a PI from an institution within the United States of America.

1.B. Eligible Individuals

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

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

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

Note: A PD/PI on one TMEN application is NOT eligible to serve as PD/PI on another TMEN application.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Application. An applicant institution may submit more than one application, provided they are scientifically distinct and proposed by different PDs/PIs.

Resubmissions. Resubmission applications are NOT allowed in response to this FOA.

Renewals. Renewal applications are NOT allowed in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html), with the exceptions defined in Section IV.6. Other Submission Requirements.

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.

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PDs/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PDs/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/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 PDs/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 PDs/PIs are from more than one institution.

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

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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 (NoA).

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

3. Submission Dates and Times

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

3.A. Receipt, Review, and Anticipated Start Dates
Letter of Intent Receipt Date: December 20, 2010
Application Receipt Date: January 20, 2011
Peer Review Date: May/June, 2011
Council Review Date: August, 2011
Earliest Anticipated Start Date: September 2011

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:

Suresh Mohla, Ph.D.
Chief, Tumor Biology and Metastasis Research
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, EPN Room 5038, MSC 7364
Bethesda, MD 20892-7364 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-1878
FAX: (301) 480-0864
Email: mohlas@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and 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 (for U.S. Postal Service regular or express mail)
Bethesda, MD 20817 (for non-USPS service)

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a competing 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 the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm).

Note specific to this FOA: Budget requests are limited to activities of the proposed Research Center, excluding the developmental and joint trans-Network activities. The developmental and joint trans-TMEN activities (to be decided later by the TMEN Steering Committee) will be supported by additional NCI funds as appropriate.

6. Other Submission Requirements and Information

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

a)     12 pages for Overview of the Research Center;

b)    6 pages for Leadership and Applicant Group;

c)     12 pages per each Research Project;

d)    12 pages per Administrative Core;

e)     6 pages for each Shared Research Resources Core; and

f)      12 pages for Proposed Developmental/Collaborative Activities.

Applicants must demonstrate in the application their ability to meet:

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to include the following sub-sections A-E under Section 3 “Research Strategy” of the PHS 398 Research Plan:

A. Overview of the Proposed Research Center;

B. Leadership and Applicant Group;

C. Capabilities for Collaborative Activities

D. Research Program (2-4 Research Projects);

E. Administrative Core

F. Shared Research Resources (Cores); and

Budget

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

Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5). Include appropriate budget pages for any sub-contractual arrangements proposed.

Use additional Form Pages 4 and 5 to provide detailed separate budget information (first year and cumulative budgets for the entire project period) for the following individual application components:

RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:

Other sections of the PHS398 Research Plan remain unmodified and should be completed following standard instructions

A. Overview of the Proposed Research Center (up to12 pages).

Define the major research questions and opportunities related to tumor-host interactions that are proposed as the focus area of the Center. Provide rationale for the importance of those questions to human cancer research. Outline the themes of the proposed individual research projects and interactions among them. Indicate benefits from an interactive research model.

Use this section to highlight: 1) the innovative capabilities of the proposed Research Center and the multidisciplinary breadth of the approaches proposed; 2) your anticipations regarding the emergence of new strategically important research directions; and 3) general plans to ensure flexibility in redirecting research when scientific progress warrants it.

B. Leadership and Applicant Group. (up to 6 pages)

In this section, address the following aspects:

Note 1: It is expected that the tasks associated with the leadership of TMEN Research Centers will require substantive effort (a minimum commitment of 3 person-months-effort per year is anticipated from each TMEN PD/PI, including each of multiple PDs/PIs, if applicable).

Note 2: The roles and expertise of all key personnel, collaborators, and consultants should be properly documented (letters from collaborators and consultants, etc. should be provided in the standard Section 14 “Letters of Support” of PHS 398 Research Plan).

Note 3: Whereas this Section B should provide overview of team capabilities, details on the group collaborative capabilities are to be provided in Section C below.

C. Capabilities for Collaborative Activities (up to 12 pages)

In this section, applicants are expected to:

Note that specific developmental and joint activities to be pursued by TMEN will be decided later by the TMEN Steering Committee. These activities will be supported by additional NCI funds as appropriate. Therefore, joint and developmental activities are NOT to be included in budget requests for individual TMEN Research Centers.

D. Research Program (2-4 research projects, up to 1 page Specific Aims plus 12 pages Research Strategy per project)

This section must conform to the following requirements:

Note: Applicants must adhere to the specified number of research projects (2-4). Applications with project number outside of this range will be considered non-responsive and returned without review.

E. Administrative Core (up to12 pages)

Each proposed TMEN Research Center must establish an Administrative Core. In this section, summarize the proposed administrative structure, and outline its anticipated functions. Outline plans for specific administrative activities within the proposed Center as well as across the Network (including interactions with the TMEN Steering Committee). In addition, describe any relevant activities related to the relationships between the proposed TMEN Center and other research, academic, and administrative units of the applicant institutions and the central administration.

The Administrative Core is also expected to provide logistical support for the required External Advisory Panel. Describe the desired expertise and anticipated structure and function of the External Advisory Panel. However, it is essential that potential members ARE NOT named, contacted, or selected until an award has been made. This delay will allow a wider pool of potential reviewers of the application.

Applicants must plan for the External Advisory Panel to meet annually to review the Center’s activities and provide guidance. Costs of the activities related to the External Advisory Panel should be included in the budget of the Administrative Core.

F. Shared Research Resources Cores (optional: up to 2 cores allowed, up to 6 pages per core).

Depending on the needs, the proposed TMEN Research Center may establish shared resources cores to serve their research program. No more than 2 such cores may be proposed. Each Core proposed should serve at least two research projects.

These shared resources must not duplicate analogous NIH-funded resources already established in the applicants’ institutions (although supplemental funding to such existing resources may be requested).

The description of each Shared Resources Core proposed must include:

Applicants must agree to adhere to all the responsibilities and obligations defined in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award.

Note: Willingness to share data and research resources is to be addressed elsewhere, in separate Section 15. Resource Sharing Plans of the PHS 398 Research Plan (see details below).

Travel Funds (include under budget for Administrative Core). Applicants must budget for travel to the semi-annual Steering Committee meetings. In all years, two investigators (the PD/PI and another senior investigator) are expected to attend two TMEN Steering Committee meetings/year.

In addition, applicants must budget for travel by at least four members of their group (other than the PD/PIs or senior investigators) in either TMEN Steering Committee meetings or other TMEN-organized workshops and symposia (i.e., a minimum of two-three trips per year).

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD only, and 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 should be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

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

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

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

Additional considerations specific to this FOA to address in the Data Sharing, Resources, and Intellectual Property Plan

Data Sharing: Whenever appropriate, the proposed data types and outputs for sharing are expected to comply with data standards of the Cancer Biomedical Informatics Grid (caBIG®, https://cabig.nci.nih.gov) as a unified platform for sharing and disseminating information.

Resources Sharing: Consistent with achieving the goals of this program, it is expected that all resources (unique materials, reagents, and procedures) generated through the TMEN Research Center awards will be shared with other TMEN investigators. Resource sharing plans would be expected to describe the type(s) of resources that may become available through the proposed center.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

Overall Impact.

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

Scored Review Criteria.

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

Significance. 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?

In addition, specific to this FOA:

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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?

In addition, specific to this FOA:

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

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

In addition, specific to this FOA:

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? 

Additional Review Criteria

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit.

A. Overall Integration of the Research Center (including Administrative Core)

B. Review Criteria for Individual Research Projects:

C. Review Criteria for Shared Resource Core(s) (IF APPLICABLE): 

Additional Review Criteria (for the entire application)

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

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

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.

Resubmission Applications.  Resubmissions are not applicable to this FOA.

Renewal Applications.  Renewals are not applicable to this FOA.

Revision Applications.  Revisions are not applicable to this FOA.

Additional Review Considerations

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

Applications from Foreign Organizations. Foreign are not applicable to this FOA.

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

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).

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.

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Awardees and Principal Investigator Rights and Responsibilities

The PD/PI (or multiple PDs/PIs, if applicable) under the TMEN auspices will have primary responsibilities in the following areas:

In addition to these responsibilities and obligations, the PDs/PIs and their awardee institutions will be accountable for implementing the approved research resource sharing plan.

All institutions/organizations participating in a given Research Center will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the Research Center award.

Each Research Center and the entire TMEN program initiative will be subject to external evaluation (coordinated by the NIH). TMEN Awardees will be expected to participate in such evaluations.

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

2. A.2. NIH Responsibilities

A designated NCI Program Director serving as a Project Scientist/Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Main NCI responsibilities include the following:

The NCI (and NINDS, if involved) reserves the right to adjust funding, withhold, suspend, or terminate the support to those TMEN awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

The substantially involved NCI Project Scientist/Coordinator will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as Project Scientist/Coordinator). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above. When NINDS funding is involved, the NCI Program Official will coordinate decisions with NINDS program staff, especially actions that involve budgetary adjustments.

2.A.3. Collaborative Responsibilities

Steering Committee: The Steering Committee will be the main governing body for the TMEN, as defined below.

The TMEN Steering Committee will consist of the following voting members:

Additional NIH staff members may participate in Steering Committee meetings as non-voting members as needed (for example to provide additional expertise). The non-voting members may include representatives from NCI extramural divisions and a representative from the NCI Center for Bioinformatics. An NINDS staff member will also be invited to participate in these meetings, assuming one or more Research Center(s) is supported partially or fully by NINDS.

The chair of the Steering Committee will be selected from the representatives of all awardee.

The Steering Committee will meet twice every year, at locations selected by the Steering Committee in consultation with the NCI.

Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientist/Coordinator will serve on such sub-committees, as he/she deems appropriate. A representative of NINDS staff members may also serve on subcommittees, if NINDS funds (or co-funds) any TMEN Research Centers.

The Steering Committee will have primary responsibility for:

2.A.4. Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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.

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


Interested investigators are strongly encouraged to discuss their ideas with involved NCI program staff prior to submission of an application to ensure that the proposed research priorities, team, and center organization will be responsive to this FOA. We welcome the opportunity to answer any other questions related to this FOA from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Suresh Mohla, Ph.D.
Chief, Tumor Biology and Metastasis Research
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, EPN Room 5038, MSC 7364
Bethesda, MD 20892-7364 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-1878
FAX: (301) 480-0864
Email: mohlas@mail.nih.gov

Jane W. Fountain, Ph.D.
Program Director
Neural Environment Cluster
National Institute of Neurological Disorders and Stroke
Neuroscience Center
6001 Executive Blvd., Room 2110
Bethesda, MD  20892-9521 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for non-USPS delivery)
Phone: (301) 496-1431
FAX:  (301) 402-2060
E-mail:  fountai@ninds.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express 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:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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


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