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: Physical Science-Oncology Centers (U54)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-CA-09-009

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.399

Key Dates
Release Date: December 9, 2008
Letters of Intent Receipt Date: February 13, 2009
Application Receipt Date: March 13, 2009
Peer Review Date: July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 2009
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 14, 2009

PRE-APPLICATION MEETING

The NCI anticipates holding a pre-application meeting several weeks prior to the application receipt date deadline to which all interested prospective applicants are invited. NCI program and review staff members will make presentations to explain the goals and objectives for the Physical Sciences-Oncology Centers (PS-OCs), to discuss the application peer review process, and to answer questions from the attendees.  An NCI Grants Management Specialist will be available to answer financial questions.  A Notice with the date and time of the meeting will be issued in the NIH Guide for Grants and Contracts (go to http://grants.nih.gov/grants/guide/index.html).

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements 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
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration 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

The purpose of this funding opportunity announcement (FOA) is to develop Physical Sciences-Oncology Centers (PS-OCs), both individually and collectively as a collaborative Network (PS-OCs as a whole will be referred to as the “Network”), that will bring together experts from the fields of physics, cancer biology, physical chemistry, mathematics, and engineering.  PS-OCs are expected to assemble and develop the infrastructure, capabilities, research programs, and teams required to catalyze a fundamentally new understanding of the emergence and behavior of cancer based on a unifying physical sciences-based thematic approach.  These coordinated trans-disciplinary Centers will develop and test, through inter-Network collaborative activities and projects, innovative cancer-focused conceptual frameworks, concepts, and hypotheses. The initiative is expected to create new fields of study in cancer that are based on physical science principles and approaches.

To provide appropriate perspective and insights, the Principal Investigator (PI) on an application submitted in response to this FOA must be a scientist with formal training and expertise in the physical sciences and/or engineering.  Even though this FOA does not allow for multiple Principal Investigators (PIs), each applicant team must also include a senior co-investigator with formal training and expertise in the biological and/or clinical sciences.

Background

The National Cancer Institute (NCI) is exploring new and innovative approaches to better understand and control cancer through initiatives that enable the convergence of the physical sciences with cancer biology.   Building on stunning progress in the molecular sciences and advanced technologies, the NCI envisions substantial benefits from the application of physical sciences to address major questions and barriers in cancer research.  The engagement of scientific teams from the fields of physics, mathematics, chemistry, and engineering to examine cancer using new, and perhaps non-traditional, approaches, is the focus of this FOA.  Specifically, NCI’s initial goal is to join these often disparate areas of science by building a collaborative Network that is composed of PS-OCs that will collectively advance our understanding of the physical laws and principles that shape and govern the emergence and behavior of cancer at all scales.

Some of the major advances in cancer research in the past decades have resulted from a new perspective derived through a combination of: (1) challenging “accepted” dogma; (2) generating orthogonal (i.e., independent and comprehensive) sets of data and integrating them with existing knowledge; and (3) integrating novel conceptual approaches from different fields.  For example, Stephen Paget’s seed-and-soil hypothesis, Judah Folkman’s anti-angiogenesis strategy, and Peter Nowell’s clonal evolution and multistep tumorigenesis have all impacted our understanding of aspects of cancer that ultimately led to new and more effective interventions.  Each of these concepts challenged prevailing cancer dogma and required orthogonal sets of experimental data to substantiate before being adopted by the mainstream cancer community.  (For additional background and/or reference, please see a recent compilation of Milestones of Cancer [http://www.nature.com/milestones/cancer].)

Researchers studying cancer biology have made enormous progress in the past few decades, yet many fundamental questions remain unanswered and lack robust, unifying principles, such as those that exist in physics .  With the advent and integration of increasingly advanced molecular/genetic techniques, cancer researchers are able to address research questions of increasing complexity, e.g., from the effects at the level of single genes, proteins, or pathways to perturbing and dissecting overall systems behaviors. These complex analyses are facilitated by the availability of various high-throughput oligo/protein/cell technologies (e.g., arrays).

Despite the progress in molecular oncology and increasing understanding of the complexity of cancer, the physics underlying cancer-relevant perturbations remains virtually unexplored and not understood.  While embracing advanced technologies, the large and complex field of cancer research has not actively and effectively engaged members of the physical sciences communities as partners. It is becoming apparent that the physical principles and laws that define the behavior of matter are profoundly important in developing an understanding of the initiation and evolution of cancer at all length-scales (i.e., ranging from sub-molecular, molecular, cellular, tissues, organisms, to populations).  In fact, the complexity of cancer may possibly be better understood through the application of approaches used in the physical sciences to comprehend complex problems.

To further explore how the NCI could more effectively engage the physical sciences in cancer research, strategic “think tanks” were convened during 2008 to bring together a large number of leaders from the fields of physical sciences and engineering with leaders in the fields of cancer biology and clinical oncology.  A near-universal consensus from these meetings was that physical scientists have unique knowledge and expertise that will be crucial for studying cancer’s overall complexity.  For example, developing knowledge about the role of such fundamental parameters as energy, gradients, static and other dynamic forces, spatial, temporal, and thermodynamic effects related to the initiation and progression of cancer may improve the understanding of metastasis and inspire new research and treatment approaches to control this deadly aspect of the disease.  Understanding the physical nature of other critical parameters in cancer may also enable new approaches to address practical challenges such as drug delivery, managing metastasis, and the emergence of drug resistance.

Four general themes emerged from these NCI-sponsored think tanks as new areas of investigation that are critical to understanding and ultimately controlling cancer:

A. Understanding the Physics (Physical Laws and Principles) of Cancer (e.g., thermodynamics, fluid dynamics, forces, cell- and bio-mechanics) by expanding our knowledge of how physical laws governing short-range and other forces, energy flows, gradients, mechanics, and thermodynamics, among other properties, affect cancer cells versus normal cells and contribute to the complexity of cancer.

B. Exploring and Understanding Evolution and Evolutionary Theory in Cancer from a Physics Perspective through the incorporation of theories of Darwinian and somatic evolution with experimental approaches from the physical sciences to better define and understand and control cancer at all length scales.

C. Understanding the Coding, Decoding, Transfer, and Translation of Information in Cancer at the molecular and submolecular levels, throughout the cellular microenvironment and beyond. The goal is to determine the impacts of information flows in cancer cells along multiple length- and time-scales and to understand how these impacts differ from what occurs in normal cells and tissues.

D. Deconvoluting the Complexity of Cancer (Computational Physics) through the development of the language, standards, and theoretical constructs required to develop dynamic, physics-based modes of cancer complexity.

Specific Research Objectives

To generate new knowledge and fields of study that effectively integrate the physical science and cancer research, PS-OCs will be expected to create a virtual center organization that focuses its efforts on one of the themes outlined in the Background section above as the organizing framework for the Center, but may also incorporate other themes in support.  Themes other than those listed can be proposed if they are adequately justified for their relevance to cancer.  Applicants proposing the organizing framework that defines the overall research directions and projects for the PS-OCs must plan to address major barriers and fundamental questions in cancer research (not narrow questions pertaining to a specific disease or model).  

Organizing Framework of PS-OCs

In the context of these major barriers/fundamental questions in understanding and controlling cancer today, examples of single themed organizing frameworks that could be pursued by a PS-OC might include, but are not limited to, the following:

A.     Physics (the Physical Laws and Principles) of Cancer: Defining the role(s) of thermodynamics and mechanics in metastasis and determining how this knowledge might be employed in new intervention strategies.

B.     Evolution and Evolutionary Theory of Cancer: Developing a comprehensive theoretical inclusive construct that would provide a foundation for understanding and predicting cancer heterogeneity.

C.    Information Coding-Decoding-Transfer and Translation in Cancer: Pursuing theoretical and supportive experimental approaches that define what information is and how it is decoded and managed in terms of cell signaling and contextual information translation in cancer.

D.    “De-convoluting Cancer’s Complexity: Pursuing theoretical and experimental approaches from the physical sciences to cancer complexity that will inform a new fundamental level of understanding of cancer that may facilitate prediction of viable pathways to develop novel interventions.

Applicants may propose organizing frameworks that combine more than one of the themes, if they are adequately justified for their role in cancer.  For example, a PS-OC might be organized to emphasize the application of excellence and expertise in evolution and evolutionary theory to address the broad question of metastasis or the heterogeneous nature of cancer.  More than one of the themes above could be applied to understand the physics of cell signaling in cancer by investigating the information flow and translation that drives the initiation and formation (i.e., evolution) of tumors.  To ensure collaborations across the Network, all PS-OCs will be expected to disseminate and cross-test outcomes and results to investigate the broader applicability of their findings.

Research Projects of PS-OCs

To develop new information and build new bodies of knowledge, PS-OCs will also be asked to propose research projects that support and substantiate the overall Center’s organizing framework (chosen from one of the thematic areas outlined, or a scientifically justified alternative) as applied to a major cancer research barrier/fundamental problem.  To meet NCI’s goal of collaborations across and outside the Network and to reduce cycles of learning, PS-OC project leaders and other team members will also be expected to disseminate and cross-test outcomes and results to ensure the robust and adaptable nature of their proposed projects.  All ideas, if sufficiently supported scientifically, will be considered.  

Examples of some important areas/questions that could represent focus areas for PS-OC projects to facilitate broader cross-Network collaborations might include, but are not limited to, the following:

Organizational Infrastructure of Individual PS-OCs and the PS-OC Network.

Each awarded PS-OC will be a “virtual” center, headed by a Project Director/Principal Investigator (PD/PI), that is composed of laboratories and research facilities which must include two or more collaborating institutions in various sites throughout the country or the world.  The PI must be trained and have significant experience in the physical sciences and the other lead investigator must be trained in and have significant experience in areas of basic and/or clinical cancer research.  Each PS-OC will be established as a collaborative trans-disciplinary research team of investigators with complementary abilities focused by an organizing construct that addresses major questions/barriers in cancer research, which are substantiated through projects that support the overall center framework.  Each PS-OC will be governed by a Center Advisory Committee (CAC) consisting of four voting key Center personnel of whom one must be the PI (with two investigators representing physical sciences and two representing biological or clinical cancer research sciences), non-voting external scientific advisors, and one voting NIH/NCI Project Scientist.  The CAC will meet at least twice per year, and as needed, to ensure Center progress.  Applicants must provide a signed, binding agreement between all institutions comprising a single PS-OC to share knowledge, research materials, and any other resources necessary and relevant to the PS-OC’s particular focus. 

Applicants must be prepared to identify non-affiliated experts as non-voting external scientific advisors to the CAC.  The applicants should describe the desired scientific profiles of such external advisors.  However, in order not to adversely affect the process of peer review of the applications, names of such individuals must not be provided in the application.  Moreover, the applicants must not contact these individuals unless their application is selected for funding after the completion of the peer review process.

A PS-OCs Steering Committee for all PS-OC awardees (PSC) will serve as the main governing board for the PS-OCs Network.  The PSC will be jointly established by all the awarded Centers and NCI PS-OC program staff members.  The PSC will consist of: (a) two representatives from each awarded Center (one of whom must be the PI), who will collectively have a single vote for each Center; and (b) three NCI PS-OC Project Scientists, who will collectively have three votes for the NCI.  The setup is designed to allow NCI program staff to facilitate and promote inter-Center collaboration pilot projects based on synergistic Center expertise and projects.  Depending upon the actual number of awardees, the ratio of NCI votes to votes of other members of the PSC will be adjusted accordingly to ensure the ratio does not exceed 1:3.  This ratio will be maintained in the future based on by-laws established by the PSC.

Each applicant team proposing a PS-OC must demonstrate the following critical components explicitly (provide examples and plans) and all components must be included for an application to be responsive to this FOA. :

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 Cooperative Agreement (U54) 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 NIH staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award.”  Awards made under this program will continue as Cooperative Agreements throughout the term of award.

2. Funds Available

The estimated amount of funds available for support of four to six projects awarded as a result of this announcement is $15M - 21M dollars for fiscal year 2009.  Future year amounts will depend on annual appropriations.

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.

F&A 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:

1.B. Eligible Individuals

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

The PI must be a scientist with formal training and expertise in the physical sciences and/or engineering.  Each applicant team must also include as a senior co-investigator another scientist with formal training in the biological and/or clinical sciences.

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

Resubmission applications are not permitted in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct and led by different PIs.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms modified as outlined below.

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

PS-OC U54 applicants must demonstrate in the application their ability to meet:

Supplemental Instructions for the Preparation of Multi-project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format.  Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.

All applications must be submitted on PHS Form 398.  The multi-project grant application should be assembled and paginated as one complete document.

Table of Contents (PHS 398 Form Page 3): Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application to account for the modified sections of the Research Plan (see below).  At a minimum, the table of contents will need to include the following sections:

Bearing in mind that the application will be scientifically reviewed framework-by-framework and project-by-project, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application, as well as to each component research project and infrastructure.  A page reference should be included for the budget for each project and each core.  Furthermore, each research project should be identified by number (e.g., Project 1), title, and Project Leader, and each infrastructure unit should be identified by title and Leader.  The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

Budget (PHS 398 Form Pages 4 and 5): 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).

Use additional Form Pages 4 and 5 to provide separate budget information for the following individual application components:

RESEARCH PLAN: The standard PHS398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as “Sections A-D”) is altered as follows:

Note: Numbers of pages “suggested” below for individual sections are provided solely as a nonbinding guidance for applicants.  Applicants are encouraged to use the minimum number of pages necessary to describe the research plan clearly and succinctly.

Other items of the PHS398 Research Plan remain unmodified.

Section N1. Overall Description of the PS-OC (up to 30 pages suggested)

Present the overall vision for the proposed PS-OC including the following segments:

Section N2. Individual C enter Projects (limited to 15 pages per each Project).

Each application should consist of three to five component projects closely pertinent to a research theme outlined in Section I of the FOA.

Describe each research project in sufficient detail to enable reviewers to judge its scientific merit.  The description of each Project must contain the following elements:

                                          i.    Project Overview -- including the rationale and description of how it fits into overarching organizing framework;

                                        ii.    Specific Aims;

                                       iii.    Background and Significance;

                                       iv.    Preliminary Studies; and

                                         v.    Research Design and Methods.

Section N3.  Center Organization and Infrastructure (up to 25 pages total suggested).

It is expected that each awardee will organize administrative units to support and coordinate project administration within the individual PS-OC and coordinate the center’s CAC and participation in the PSC.

In this section, describe administrative structure and units to support the proposed PS-OC that include, but are not limited, to:

The PI is encouraged to propose a project manager for the center to manage the day-to-day operations.  All center applicants are expected to apply process management methods for planning, monitoring, and managing the workload over the award period and are expected to communicate this to NCI program staff upon request.

Describe the coordination of bioinformatics efforts and other anticipated efforts to share data across the participating institutions.  Include your vision for the interaction in this regard with other PS-OCs and the NCI.

Section N4. Other Critical Resources and Capabilities (up to 20 pages total suggested)

Shared Research Resources Cores (equivalent to “Shared Research Capabilities” in the terminology of the National Science Foundation). Applicants may propose one or more (up to 3, as needed) appropriate shared technical resources, or cores. Applicants must also describe how the proposed cores will facilitate the PS-OC research projects. These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested).

Describe additional infrastructure, including: Education and Training Unit, and Outreach and Dissemination Unit for the individual PS-OC in sufficient detail to enable reviewers to judge its scientific merit.

All descriptions of each component must include:

In addition to overall items listed above, the following units will need to include, but are not limited to:

Education and Training Unit

Outreach and Dissemination Unit

Applicants should take maximal use of the existing resources, institutional cores, etc.  No duplication of existing NIH-funded shared resource cores will be allowed.

Foreign Organizations (Non-Domestic [non-U.S.] Entities)

NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

In addition, for applications from Foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Additional information is available in the PHS 398 grant application instructions and in Other Submission Requirements and Information below (Section IV.6).

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: February 13, 2009
Application Receipt Date: March 13, 2009
Peer Review Date: July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 23, 2009

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 NCI 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:

Dr. Jerry S. H. Lee
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 11A30C, MSC 2590
Bethesda, MD 20892-2590
Telephone: (301) 496-1045
FAX: (301) 480-2889
Email: leejerry@mail.nih.gov

and

Dr. Larry A. Nagahara
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: nagaharl@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 Express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)

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 Express or regular mail)
Rockville, MD 20852 (for non-U.S.P.S. delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefgrp@mail.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 NCI.  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 PI in the eRA Commons at https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a competing 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).

6. Other Submission Requirements and Information

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI2.A “Award Administration Information.”

Because of the complexity of the PS-OCs, NIH/NCI program staff members will conduct annual administrative site visits.  PS-OCs should be prepared for annual visits and should budget appropriately (including travel for collaborators and other necessary costs).

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs 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 of the Research Plan component.  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 the 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/.

Specific Instructions for Foreign Applications

All Foreign applicants must complete and submit budget requests using the Research & Related (R&R) Budget component found in the application package for this FOA.  See NOT-OD-06-096, August 23, 2006.

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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the 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 scientific peer review, all applications will:

The following will be considered in making funding decisions:

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

Significance: Does this study address an important problem?  If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, and/or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PI and other researchers?  Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?

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

The application will receive an overall priority score that reflects: 1) the synergy and strength of the Center as a whole; 2) the scientific merit of the proposed organizing framework, projects and facilities; and 3) the scientific merit of the proposed interactions with other awardees in the PS-OCs Network.

The applications will also be assessed according to the following criteria:

Review Criteria for Overall PS-OC

1.  Significance: Does the overall novel organizing framework based on a physical science question of cancer processes provide a ‘fresh perspective’ of the disease?  What is potential for impact?  What will be the effect of these studies on the concepts, methods, and technologies that drive this field?

2.  Team Science: Does the proposed structure support and nurture a team science environment that: (1) incubates and tests novel cancer concepts by challenging ‘accepted’ dogmas; (2) can generate orthogonal sets of physical measurements and integrate them with existing knowledge; and (3) can develop dynamic computational physics model(s) which substantiate(s) experimental results and more importantly provide(s) a comprehensive, predictive model of cancer across multiple length and temporal scales?

3.  Facilities: Are facilities adequate for the overall functions of the Center and to implement goals of the PS-OCs program?

4.  Integration: Is there evidence of scientific and administrative integration of the proposed PS-OC?  Is there evidence of coordination, interrelationships, and synergy among the individual research projects and other components? Are there adequate plans for ensuring effective communication, interaction, and coordination among the PS-OC investigators, PS-OCs Network, and NCI/NIH staff?  Do the applicants state their willingness to collaborate extensively and share information, data, software, and other resources fully, consistent with meeting the goals of the program and with the applicant/s submitted statements and applicable grant regulations?

Review Criteria for Center Research Projects

1.  Significance: Does this study address an important problem? Does the project complement the overall Center organizing framework?  

2.  Approach: Are the conceptual design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  Does the project take advantage of the Center infrastructure to allow for alternative tactics of projects to be carried out with minimal time-delay?

3.  Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4.  Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers?  Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5.  Environment: Does the scientific environment in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?

Additional Review Criteria for Shared Research Resource Cores

1.     Are the proposed shared resource cores appropriate and within the context of the overarching organizing framework and proposed research activities?

2.     Are the plans for prioritizing the use of shared resource cores, for allocating availability to the proposed Research Projects, and for ensuring that the core facilities are used to the fullest extent, including access by non-PS-OC investigators and institutions, feasible and clear?

3.     Are the qualifications, experience, and commitments of key personnel for running the facilities appropriate?

Additional Review Criteria for Education and Training Unit

1.     Are there sufficient and appropriate technical and scientific expertise, mentoring experience, and available faculty and staff to conduct the proposed training?

2.     Is the documented available training infrastructure, such as laboratories, clinics, etc., sufficient for the proposed career development and training activities?

3.     Does the proposed training relate to and integrate with the goals of the overarching organizing framework of the PS-OCs?

4.     Are the plans for evaluating training and documenting success suitable?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed.  Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

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

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources.  However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA.  Program staff members within the NCI will be responsible for monitoring the resource sharing.

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 (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.

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 PI 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. Awardee’s and Principal Investigator’s Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

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

NIH program directors, acting as Project Scientists, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientists will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications.  If such participation is 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 the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice.  A Program Official may also have substantial programmatic involvement (as a Project Scientist).  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.

2.A.3. Collaborative Responsibilities

The PS-OCs Steering Committee (PSC) will serve as the main governing board for the PS-OCs Network.  The PSC will be jointly established by all the awarded Centers and involved NCI program staff.  The PSC will consist of: (a) two representatives from each awarded Center (one of whom must be the PI), who will collectively have a single vote for each Center; and (b) three NCI Project Scientists, who will collectively have three votes for the NCI.  The setup is designed to allow NCI program staff to facilitate and promote inter-Center collaboration pilot projects based on synergistic Center projects.  Depending upon the actual number of awardees, the ratio of NCI votes to votes of other members of the PSC will be adjusted accordingly to ensure the ratio does not exceed 1:3.  This ratio will be maintained in the future based on by-laws established by the PSC.

In addition, the designated NCI Program Director will participate in the activities of the PSC as a non-voting member.  Additional members (without voting rights) to serve in advisory capacity may be added to the PSC by majority vote of the existing voting committee members.  These additional non-voting members may include other NCI and NIH program staff and/or program staff from other federal agencies (e.g., Food and Drug Administration [FDA], National Institutes of Standards and Technology [NIST], and Department of Defense [DoD]).

The PSC will elect one of the PS-OC PIs as its chair for an 18-month-long term starting at the first meeting of the PSC following award.

All PSC decisions and recommendations that require voting will be based on a majority vote.

The PSC will have primary responsibility for the overall organizational oversight of the PS-OCs Network and for reviewing the research goals among the Centers. 

Responsibilities of the PSC will include the following:

Awardee members of the PSC will be required to accept and implement policies approved by the PSC.

2.A.4. Arbitration 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 arbitration.  An Arbitration 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 arbitration procedure in no way affects 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.

The PI of each PS-OC will be responsible for organizing an annual report on all of the activities of his/her center to be reported to the NCI/NIH.  The PI of the PS-OC will also be providing an additional semi-annual (every 6 months) report to NCI based upon the format discussed and agreed upon by the PSC.

Site visit reporting. NIH/NCI program staff members will conduct annual administrative site visits.  PS-OCs will be expected to report on their progress during these annual administrative site visits.

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:

Dr. Jerry S. H. Lee
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 11A30C, MSC 2590
Bethesda, MD 20892
Telephone: (301) 496-1550
FAX: (301) 480-2889
Email: leejerry@mail.nih.gov

and

Dr. Larry A. Nagahara
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 10A52, MSC 2580
Bethesda, MD 20892
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: nagaharl@mail.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:

Leslie Hickman
Office of Grants Administration
National Cancer Institute
Fairview Center Building, Suite 300
1003 West 7th Street
Frederick, MD 21701-4106
Phone: (301) 846-1013
FAX: (301) 451-5391
E-mail: HickmanL@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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the 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/

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.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. Applications that do not provide this information will be returned without review.

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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