Expired RFA-CA-08-002: Network for Translational Research (NTR): Optical Imaging in Multimodal Platforms (U54)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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.nci.nih.gov)

Title: Network for Translational Research (NTR): Optical Imaging in Multimodal Platforms (U54)

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-03-002, which was previously released August 27, 2002.

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

October 18, 2007 - See Notice (NOT-CA-08-001) Notice of Pre-Application Meeting.

Request For Applications (RFA) Number: RFA-CA-08-002

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

Key Dates
Release Date: October 12, 2007
Letters of Intent Receipt Date: December 24, 2007
Application Receipt Date: January 24, 2008
Peer Review Date: June/July 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 2008
Additional Information To Be Available Date (URL Activation Date):
Not Applicable.
Expiration Date: January 25, 2008

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) issued by the National Cancer Institute (NCI) is an open competition initiative, designed to continue the efforts of the NCI to develop and translate cancer-relevant optical imaging technologies as a part of an overall imaging program for early cancer detection, diagnosis, therapeutic response, drug development, and image-guided therapy. This FOA stems from the previous initiative on optical imaging technology (covered by RFA-CA-03-002). However, the program structure and goals of the current FOA differ from those of the original program. Accordingly, all responses to this FOA will be considered new applications, with the main objective being to accelerate the translational research of in vivo multimodal imaging and/or spectroscopic platforms from the laboratory and pre-clinical level to the clinical level. Applications are sought from multi-disciplinary, multi-institutional research teams. After the awards, successful teams will become Centers that will be organized into an interactive network. The network will be called the Network for Translational Research: Optical Imaging (NTR). The purpose of NTR is to develop, optimize, and validate imaging technology platforms and methods so that they can enter single or multi-site clinical trials and eventually be incorporated into clinical practice. Applicants responding to this FOA must identify a specific cancer-relevant clinical goal and propose to develop and validate at least one multimodal imaging platform, as defined in this FOA, to address this clinical goal.
Mechanism of Support. This FOA will utilize the NIH Specialized Centers Cooperative Agreement U54 award mechanism.
The total amount to be awarded. The NCI anticipates making awards of up to 5 years in duration under this FOA. The amount of funding set-aside for this program each year is $4.8M, for a total of $24M over the 5-year period.
The anticipated number of awards. The NCI anticipates making approximately four awards under this FOA.
Eligible organizations. Eligible organizations include: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organization (Other than Small Business); State Government; U.S. Territory or Possession; Non-domestic (non-U.S.) Entity (Foreign Organization); Regional Organization; Eligible agencies of the Federal government
The NCI strongly encourages that each responding applicant team includes researchers from at least two different institutions to ensure a broad range of expertise needed for NTR. In addition, the involvement of industry partners (i.e., small or large companies) in the research activities of each Center is particularly encouraged.
Eligible principal investigators. Individuals with skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Only new applications are allowed. Neither renewal nor resubmission applications will be accepted.
Applicants may submit more than one application, provided they are scientifically distinct (i.e., applications that address separate clinical cancer imaging problems and propose different technology platforms for development).
See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

This Funding Opportunity Announcement (FOA) is designed to support translational research needed to bring imaging technologies closer to clinical practice in a timely manner. Specific emphasis is on the development of multimodal imaging platforms and their validation in early stage clinical trials or clinical investigations. For this overall goal, the National Cancer Institute (NCI) invites applications for NIH U54 cooperative agreement awards to establish multi-disciplinary, multi-institutional Specialized Research Resource Centers (or Centers in this FOA).

This FOA stems from the previous initiative on optical imaging technology (covered by RFA-CA-03-002). However, the program structure and goals of the current FOA differ from those of the original program. Accordingly, all responses to this FOA will be considered to be new applications, with the main objective to accelerate the translational research of in vivo multimodal imaging and/or spectroscopic platforms from the laboratory and pre-clinical level to the clinical level.

It is becoming increasingly clear that single-mode imaging methods may not provide optimal solutions for many medical imaging tasks. Recent advances in medical imaging are increasingly often made possible through the development of multimodal imaging platforms and the use of multiple molecular probes and/or contrast agents. An important advantage of multimodal imaging is the potential to considerably improve sensitivity and specificity of cancer relevant applications over single mode imaging.

Of particular interest to this FOA is the application of optical imaging and spectroscopic methods to cancer problems. Whereas a definite progress has been made in this direction recently, there remains a need to explore the integration of optical methods with other imaging modalities to improve sensitivity and specificity for cancer problems, and to evaluate the performance of optical imaging methods against other emerging imaging modalities.

To be responsive to the objectives of this FOA, applicant teams must define a specific, clinically-relevant cancer imaging problem (i.e., an important imaging goal) as their area of focus. The proposed Center must then be organized around a research program to provide a validated solution to this goal using multimodal imaging. The proposed program must focus on combined imaging systems, referred to as imaging platforms, as defined in this FOA.

Collectively the awarded Research Centers will form a network. This network of Research Centers is to be called the Network for Translational Research (NTR), or the Network in this document. The overarching purpose for the Network is to facilitate the conduct of translational research in the area of multimodal imaging and/or spectroscopy and validation of such approaches for clinically-relevant applications. It is desirable that the academic and industrial communities work together where appropriate to develop consensus approaches for validation of multimodal imaging technologies that satisfy unmet needs in the clinical environment. Such consensus on validation approaches is expected to accelerate the dissemination of new imaging applications/platforms into clinical practice by shortening time and effort associated with formal procedures of their evaluation and approval by regulatory agencies (notably FDA).

DEFINITION OF TRANSLATIONAL RESEARCH

The term translational research, as used in this FOA, is consistent with the NCI s Translational Research Working Group definition (http://www.cancer.gov/trwg/). Specifically, this FOA seeks applications for projects designed to transform scientific discoveries arising from laboratory, animal studies, and technological advances into clinical imaging applications that would help to reduce the morbidity and mortality of cancer for patients. The imaging research problem selected by the proposed Center must therefore focus on a specific and clinically relevant aspect of cancer, and its solution must promise significant benefits in terms of detection, diagnosis, and/or treatment of that cancer type. By focusing on a pertinent clinical goal in cancer imaging through multimodal imaging platforms, this FOA has a different research scope from the original NTR initiative.

DEFINITION OF IMAGING PLATFORM

Advances in clinical imaging are being made through the development of combinations of imaging techniques, creating multimodal imaging platforms, such as PET-CT (Positron Emission Tomography-Computed Tomography), PET-MRI (Magnetic Resonance Imaging), and MRI-US (Ultrasound), as well as recent combinations using optical methods as a complementary imaging modality. Each imaging technique relies on different principles of physical interaction with tissue and, where appropriate, the use of different molecular probes. As a result, each imaging method has the potential to provide unique structural, molecular, functional, and/or metabolic information that complement other imaging methods. The complexities of integrating these different methods into combined imaging suites are thus offset by the potential for increased performance in sensitivity and specificity for screening, diagnosis, staging, treatment monitoring, image-guided intervention, and/or emerging methods that combine diagnosis and treatment. For example, multimodal imaging of targeted tissue is expected to improve patient stratification at critical decision points by reducing false positive and false negative screening, diagnostic, and/or therapeutic monitoring results.

Required Platform Attributes. A multimodal imaging platform is defined within this FOA as a suite of different imaging systems, where each imaging system [e.g., optical, X-ray, magnetic resonance imaging (MRI), radionuclide imaging, e.g., PET, SPECT (Single Photon Emission Computed Tomography), or ultrasound, may achieve one or more measurement objectives, such as anatomical, functional, and/or molecular composition information. Examples of existing multimodal imaging platforms include, but are not limited to, hybrid systems that physically combine different imaging modalities and/or offer imaging methods where the physical characteristics of one mode will complement the performance of the other (e.g. PET-CT, MRI-PET, MRI-optical, or ultrasound-optical, etc.). The systems within the proposed imaging platform(s) may include external imaging methods such as tomography or localized internal methods such as endoscopic measurements. The platform proposed for development must include at least two imaging systems to permit their optimization through comparative validation studies as defined in this FOA. Equally important is the possibility for improved imaging performance as measured by sensitivity and specificity through combined, or synergistic, performance.

The required multimodal imaging platform may include image guidance (IG) and related component technologies to permit interventional studies. IG methods may include surgical, energy deposition, or drug delivery techniques. A complete image-guided system (imaging methodology and therapy delivery system) is considered a single system within the definition of the multimodal platform in this FOA.

At least one of the imaging systems within the required platform must include an optical imaging or spectroscopic method. Inclusion of molecular and/or functional imaging based on extrinsic contrast agents, targeted probes, and/or intrinsic contrast is encouraged. It is acceptable to propose a platform that combines commercially-available and prototype systems. It is conceivable that some of the selected clinical problems might eventually be adequately served by a simpler platform than required in the initial exploration by this FOA (perhaps even a single-mode imaging device). Nonetheless, it is expected that multiple imaging and/or spectroscopic systems that detect independent physical, chemical, and/or functional parameters will yield improvements in sensitivity and specificity faster and to a greater degree than single-mode solutions. For this reason, applicants responding to this FOA are strongly encouraged to select and propose for development a multimodal imaging/spectroscopy platform(s) combining different types of imaging methodologies.

The proposed imaging platform does not need to have physically connected and/or hardware-integrated imaging systems, although full integration at the level of data and informatics will be necessary. The platform may consist of discrete imaging systems with a method for image registration that can be validated with registered spatial coordinates, or where extracted data from each imaging system can be integrated to permit synergistic clinical decision making.

The individual modalities proposed for inclusion in the imaging platform(s) must already be tried and proved to be feasible. Thus, extensive preliminary data on performance characteristics of the individual imaging systems to be included in the platform(s) should be available and provided in the application. However, the combined use of these modalities in a platform is expected to require additional developmental work at the pre-clinical and clinical level. The main thrust of the research efforts is envisaged to take place in the area of systematic integration of multiple imaging modalities and validation of the platform for the defined medical problem. These objectives should be accomplished by the end of the funding period.

Applications without adequate preliminary data as well as applications proposing invention and early-stage development of imaging techniques (e.g., the inclusion into the final platform of untried imaging systems that would require extensive de novo technology development) are not responsive to this FOA.

DEFINITION AND REQUIRED TYPES OF VALIDATION METHODS

Performance validation of the chosen multimodal platform(s) is a central task in this program. Therefore, each Center will need to define suitable performance requirements for the imaging platform(s) and then provide a strategy for its validation. These requirements will not only serve to monitor progress during the course of the program, they will assist commercial manufacturers in their future efforts to design and construct imaging platforms. Performance requirements should include standardized methods for quality assurance, criteria for data collection and analysis, accepted methods for data archiving, and operational hazards analysis. It is anticipated that completion of a list of performance requirements will best take place with inputs from other teams within the Network. Thus, the strategy sought in this FOA is a sharing across the Network of performance and validation requirements for the emerging multimode platforms.

Applicants responding to this FOA need to consider and propose, as appropriate, the following types of validation:

Imaging system(s) and platform validation. These measurements involve two broad categories of validation: (a) component systems and overall platform physical performance; and (b) quality control methods to verify the physical performance during validation and pre-clinical or clinical measurement periods. The first performance assessment may include, by way of example, the use of phantoms and simulation studies that measure parameters such detection sensitivity, image contrast, or signal-to-noise ratio, or alternatively the performance characteristics of image guidance systems. Quality control methods involve similar measurements, but address any time-related changes or issues regarding measurement reproducibility and related statistical analysis.
Preclinical validation of the proposed application (i.e., the entire platform as a solution to the proposed cancer-relevant imaging problem). Such efforts may require development and use of: (a) in vitro and/or ex vivo measurements of biopsies or excised tissues; (b) in vivo animal studies using different cancer models; and (c) probes or agents to facilitate in vivo imaging or spectroscopic studies at multiple levels (e.g., as appropriate, anatomical, functional, and/or molecular levels). The use of animal models is expected to be a critical and significant component of the validation strategy for molecular imaging methods that use molecular probes and/or agents.
Clinical validation of the proposed application. The ultimate goal of validation studies is to test and optimize the performance of the proposed imaging platform in clinically-relevant settings. The platform validation may involve, for example, cross-correlating in vivo imaging results collected by the various imaging systems within the imaging platform by using common tumor or biomarker targets, as well as by comparing/correlating the combined imaging results with recognized standards appropriate for the cancer problem to be addressed (such as pathology data and/or other relevant in vitro molecular/cellular profiling, and/or other types of imaging). To evaluate clinical performance, such results should be evaluated through comparison to an acceptable standard. Either single-site or multi-site clinical investigations may be proposed.

The use of validation methods and software tools in response to this FOA must address the issue of compatibility with the NCI caBIG (cancer Biomedical Informatics Grid) informatics initiative https://cabig.nci.nih.gov/). One of the goals of the caBIG (specifically the caBIG imaging archive and workspace initiative) is to stimulate the development of open source informatics tools and open access to bioinformatics resources and data bases. These attributes should facilitate data integration and analysis over a broad range of data collection platforms covering imaging, genomic, and proteomic resources(https://imaging.nci.nih.gov/ncia/).

It is expected that all of the funded projects will have reached the stage of single- or multi-center clinical validation studies by the end of the 5-year funding period. However, request to support large-scale clinical trials are beyond the intent of this FOA and will not be considered responsive. Applicants planning such trials are advised to consider several alternative NCI imaging initiatives that may support large clinical trials; go to http://imaging.cancer.gov/clinicaltrials/acrin/;http://imaging.cancer.gov/researchfunding/current/currentfunding; and http://grants.nih.gov/grants/guide/pa-files/PAR-05-114.html.

Requests to support validation of imaging platforms that apply to ionizing radiation therapy or to support radiation therapy clinical trials will be considered non-responsive to this FOA because the NCI has an Advanced Technology Consortium (ATC) that supports such research
(http://atc.wustl.edu/home/about.html).

ORGANIZATION OF THE NETWORK FOR TRANSLATIONAL RESEARCH (NTR)

Networking of Research Centers: The Network will consist of approximately four multi-disciplinary, multi-institutional Research Centers. The Centers will work together within the Network to develop consensus-based approaches to platform performance validation, under the guidance of a Steering Committee (SC) and External Advisory Committee (EAC) as defined below. To ensure a broad range of expertise needed for NTR as a Network and for each NTR Research Center, the NCI strongly encourages that each responding applicant team includes researchers from at least two different institutions. In addition, the involvement of industry partners (i.e., small or large companies) in the research activities of each Center is particularly encouraged. Substantive commitment of researchers from all the participating institutions is viewed as important element promoting truly collaborative nature of the proposed Research Centers. It is anticipated that to meet the requirement for the integration of diverse imaging modalities, the proposed Centers will include a multi-disciplinary range of experts from academia and industry, such as molecular biologists, chemists, physicists, optical and computing engineers, imaging scientists, and physicians. Not all basic and/or clinical scientists involved need to have cancer-relevant expertise, so long as their specialized experience is important to the success of the proposed project.

Steering Committee (SC) and External Advisory Committee (EAC). The Network will be governed by a steering committee. The SC will include representatives from the Research Centers within the Network and also from various agencies of the federal government, such as NCI programs, the NCI caBIG, NIH intramural laboratories, Food and Drug Administration (FDA), National Institute of Standards and Technology (NIST), and U.S. Department of Defence (DoD). The mandate of the SC will be to review priorities for the Network. In addition, an external advisory committee (EAC), reporting to the SC, will be created with representation that will include leading experts in multimodal imaging and translational research from academia, medical imaging and industry, including pharmaceutical companies, to encourage the broad acceptance of validation and imaging methods for clinical investigations. Members of the external advisory committee will be selected by the SC. Details on the composition and responsibilities of SC are given in Section VI. 2A3 of this FOA.

SPECIFIC OBJECTIVES AND REQUIREMENTS

The achievement of the defined clinical goal must be the ultimate objective for each applicant team. The goal can be defined by choice of cancer organ site(s), such as breast, gastrointestinal/colon, prostate, etc., or through a cancer biomarker such as angiogenesis, gene expression, cellular proliferation, or hypoxia. Applicants are also encouraged to explore paradigms that combine detection with treatment that focuses on a target cancer problem. Examples of types of appropriate cancer-relevant problems that may be addressed by the imaging platform defined in this FOA include (but are not limited to) the following imaging needs :

Pre-cancer, early cancer, or micrometastasis detection;
Screening, diagnosis, patient stratification/staging;
Quantitative measurement of responses to therapy; and
Improved image guidance of therapeutic interventions.

Inclusion of molecular imaging methods in the proposed imaging platform(s) is encouraged. In this context, prospective applicants may benefit from the interactions with investigators involved in other NCI-sponsored initiatives using various NIH funding mechanisms, notably including In vivo Cancer Molecular Imaging Centers ICMIC (P50), Small Animal Imaging Resources SAIR (U24) (http://imaging.cancer.gov/programsandresources/SpecializedInitiatives); and NCI Nanotechnology Alliance (U54 s)(http://nano.cancer.gov/index.asp). Applicant teams are also encouraged to network with investigators involved with molecular imaging technology projects sponsored by Bioengineering Research partnerships (R01 grant mechanism), NCRR (P41 grant mechanism), and/or Program Projects (P01 grant mechanism).

Requirements for Research Program Content & Structure

Each applicant team must propose a research program focused on a defined cancer-relevant imaging application. The need for imaging research and development in this area must be well justified. The strategic rationale regarding the choices for multi-modal platform(s) to be developed should be clearly outlined. Anticipated advantages of combining selected imaging modalities in one platform must be appropriate for the chosen clinical cancer imaging problem. Technologies and/or methods proposed for inclusion in the multimodal platform should be sufficiently mature as defined in this FOA.

The proposed research program should be fully developed both conceptually and methodologically. Strong preliminary data for the areas pertinent to the proposed projects should be provided. These data should support such elements as the significance of the chosen clinical imaging problem, feasibility of the approaches, availability of appropriate testing, validating models, etc. Except for data supporting cancer relevance of the chosen clinical imaging problem, these preliminary results may originate not only from cancer research but also from other fields appropriate to the goals of this FOA.

A research program proposed by each applicant team must consist of the following components:

A. Primary Project
B. Task-Specific Projects
C. Support Cores
D. Administrative Core
E. Joint Network Activities

A. Primary Project: Each applicant team must propose clearly defined ways and means to achieve the stated translational research objectives in their chosen area of cancer imaging. These main objectives, approaches, and needed research infrastructure should be described in a single Primary Project. The Primary Project must adequately address system integration and validation needs for the proposed imaging platform(s) as defined in this FOA. Specific Aims of the Primary Project should clearly define the overall plan for solving the selected clinical cancer imaging problem through the integration and validation of the multimodal platform(s). The goals of the Primary Project must comprise the completion of development and validation of clinical performance satisfactory for the chosen clinical objective of at least one imaging platform in early clinical studies. For each of the main stages in platform development, the applicant should provide relevant benchmarks (quantitative, if appropriate) and timeline to meet these benchmarks.

It is anticipated that all of the partnering institutions of the applicant team will have significant commitments to performing the Primary Project. Different specific aims, however, may be performed at different sites.

B. Task-Specific Projects: Task-Specific Projects are expected to be organized to serve the progress of the Primary Project and should be directly connected to one or more specific aims of the Primary Project. It is recognized that not all aspects of the integration and validation of a multimodal imaging platform can be fully defined at the time of the application preparation. Task-Specific Projects should be used to address identified needs for additional development/optimization prior to overall platform integration and/or to explore approaches that may offer considerable advantages for the goals of the Primary Project but are at a pilot stage and carry a level of risk. Thus, Task-Specific Projects are meant to solve problems anticipated or encountered in the Primary Project or to obtain answers that will facilitate completion of a specific aim of the Primary Project in a flexible way. Task-Specific Projects may also serve to explore backup alternatives for some aspects of the Primary Projects that might encounter unexpected difficulties. Depending on particular needs, a Task-Specific Project may support only one specific aim of the Primary Project or it may support multiple specific aims. It is anticipated that these projects can be performed at any of the sites within the structure of the Center where expertise for that Task-Specific Project is located.

Initial Task-Specific Projects and Plans to Initiate and Select Future Task-Specific Projects: It is not feasible at the time of application preparation to anticipate all the needs that could be addressed by Task-Specific Projects. Therefore, only initial Task-Specific Projects to start during the first year of the program should be described in the applications. However, applicants should describe plans outlining how future Task-Specific Projects will be formulated and selected during the following four years of the award.

Examples of Task-Specific Projects include, but are not limited to:

Feasibility studies to determine optimal approaches for the final platform design;
Component design, fabrication, testing, and/or hardware integration tasks;
Image reconstruction algorithm development for multimodal images;
Data fusion and analysis methods for the multimodal platform; and
Exploration of imaging probes/agents and/or related nano-carriers in the multimodal environment.

C. Research Support Cores: Each applicant team should also propose Research Support Cores as appropriate for their proposed research program and goals. Depending on the anticipated needs, applicants may propose one or more Support Core(s). Examples of Research Support Cores that may be appropriate include, but are not limited to:

Bioinformatics/Statistical
Image processing tools
Pathology;
Microscopy;
In vivo (animal models),
Biospecimens; and
Standards, Validation, and Quality Assurance.

D. Administrative Core: An Administrative Core is required for each proposed Center to provide overall administrative services to that Center and to facilitate coordination among all intra-Center projects and Research Support Cores. The Administrative Core must also budget for and provide inter-Center coordination (e.g., support activities of the Steering Committee).

E. Participation in Joint Network Activities

Awarded Research Centers will work jointly under the guidance of a Steering Committee on the development, harmonization, and standardization of methods for data collection and analysis across the different imaging platforms to be developed by each Center in the Network. The intent is to identify and test methods suitable for performance validation of multimodal imaging. Ideally, these efforts will lead to multi-center, multi-platform clinical studies involving all Centers in the Network before the end of the program period.

Each team will be expected to engage in activities (under the SC and EAC guidance) to create accepted approaches to standardization and information sharing across the Network. With SC and EAC oversight, representatives from each Center will be organized into working groups for the purpose of communicating information across the Network relevant to joint activities and creation and maintenance of Network-wide resources.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH U54 cooperative agreement award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The NIH U54 is a cooperative agreement award mechanism. With this cooperative agreement award mechanism, each PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed research of the Center, maintaining active collaborations to be formed with other Centers competitively selected for the Network, and maintaining active participation in the Network’s Steering Committee. NIH staff will be substantially involved as described under Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award.

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

Only new applications are allowed. Neither competing continuation nor resubmission applications will be accepted.

2. Funds Available

NCI intends to commit up to $4.8 million in total costs in fiscal year (FY) 2008 to fund approximately four competitively selected cooperative agreements in response to this FOA. A total amount of set-aside funds expected to be committed to this initiative over the entire 5 year period is $24 million.

Because the nature and scope of the proposed research will be different from one application to another, it is anticipated that the size and duration of the funded awards will vary. For most of awards, total costs are expected to range from $1,100,000 to $1,300,000 per year. An applicant may request a project period of up to 5 years with annual budget (total costs) not exceeding $1,500,000. Although financial plans of the NCI include support for this program, awards pursuant to this FOA are contingent upon the annual availability of funds and receipt of a sufficient number of meritorious applications.

Most of the funds must be budgeted for the direct support of the Primary Project and Task Specific Projects. The expected breakdown of the proposed annual costs for the different components defined in this FOA is as follows:

Primary Project and Task-Specific Projects: Direct costs to cover the development and validation of an imaging platform(s) as defined in this FOA should amount to approximately 85% of annual and cumulative direct costs requested.
Research Support Cores and Administrative Core: Direct costs to cover tasks assigned to Administrative Core and Research Support Cores as needed for each Center and for the full network, with steering committee oversight, should amount to approximately 15% of annual and cumulative direct costs requested.

NCI extramural funds are not available to support research by NIH intramural investigators. Intramural participants must verify the availability of funding allocated from NIH intramural sources to support their role as collaborators.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Public/State Controlled Institution of Higher Education;
Private Institution of Higher Education;
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education);
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education);
Small Business;
For-Profit Organization (Other than Small Business);
State Government;
U.S. Territory or Possession;
Non-domestic (non-U.S.) Entity (Foreign Organization);
Regional Organization; and
Eligible agencies of the Federal government

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

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
Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo -- Telephone: (301) 710-0267; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms (http://grants.nih.gov/grants/funding/phs398/phs398.html), but with the specific exceptions that are indicated 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.

Face Page (PHS 398 Form Page 1): The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Summary and Key Personnel (PHS 398 Form Page 2): Follow the current PHS 398 instructions.

Table of Content (PHS 398 Form Page 3): Modify the standard PHS 398 Table of Contents to account for the additional budget pages and modified content (new sections) of the Research Plan required for this FOA (see below).

Budget (PHS 398 Form Pages 4 and 5): Following the current PHS 398 instructions, use Form Pages 4 and 5, respectively, to provide a detailed composite budget (direct costs) for the entire application for the first 12-month period (Form Page 4) and the entire proposed project period as well as budget justification (Form Page 5). Follow PHS 398 instructions to reflect consortium/contractual arrangements in the budget pages (i.e., use separate Form Pages 4 and 5 for consortium sub-budgets for the first year and for the entire proposed project period).

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

A budget for the first 12-month period and a separate budget for the entire proposed project period for the Primary Project;
Individual budgets for each Task Specific Project expected to start in the first year and a cumulative budget for all Task-Specific Projects for the entire proposed project period;
A budget for the first year of the Administrative Core and a cumulative budget for the Administrative Core over the entire project; and
Individual budgets for each Research Support Core (excluding the Administrate Core) for the first year and for the entire proposed project period.

Other information pertinent to the Budget section includes the following:

Capital Equipment -- Quotes for capital equipment are not needed for application review, but will be requested prior to issuing an award;
Duplicate Equipment -- The Budget for Equipment may include funds to produce one or more copies of prototype translational equipment needed for placement with one or more collaborating research or clinical research sites (the request should be justified under Equipment in the Budget Justification); and
The Administrative Core budget must include funds allocated for Network Steering Committee needs as well as for the usual administrative core activities -- Sufficient travel funds should be planned for the PI and three (3) investigators to attend semi-annual NTR meetings.

Provide a Table of Professional Effort, starting with the PI, followed by other senior investigators and the rest of key investigators. See the following link for a sample of Table of Professional Effort: http://deainfo.nci.nih.gov/awards/P01.pdf#B.

Biographical Sketches of key personnel and Resources: Follow the current PHS 398 instructions.

RESEARCH PLAN: The standard PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html) are modified as follows:

Standard Sections A-D of the PHS 398 Research Plan are replaced by the following new Sections 1-7 (specified below).

Section 1. Overall Goals of the Proposed Center
Section 2. Team Expertise
Section 3. Institutional Environments and Resources
Section 4. Center Organization and Leadership Plans
Section 5. Primary Project
Section 6. Task-Specific Projects
Section 7. Support Cores

A maximum page limit of 50 pages total applies to the new Sections 1-7, as prescribed below. There is an additional allocation (see below) for each Task Specific Project proposed to start in year 1 and for Research Support Cores. These page limits represent the maximum allowable limit. However, applications should be as concise as possible to facilitate a thorough review.

Other sections of Research Plan (Sections E-L) are to be completed following the standard instructions.

SPECIFIC INSTRUCTIONS FOR NEW SECTIONS 1-7

Section 1. Overall Goals of the Proposed Center (up to 4 pages suggested). Provide an overview of the proposed NTR Center and its organization, reserving details for later sections. Present an overall vision, including research objectives for the Center and how it will support the translation research as defined in this FOA. Define succinctly the overarching goal for the proposed Research Center, i.e., a clinically-relevant cancer imaging problem that is to be solved by creating and validating a new multimodal imaging platform(s). Outline the proposed imaging approach to solving that problem and provide the rationale for the selected strategy. The multimodal platform(s) selected for development and validation should be appropriately defined and potential advantages summarized. The specific goals of the primary project and its expected results should also be clearly stated in this overview section.

Section 2. Team Expertise (up to 4 pages suggested). Briefly describe the highlights of the relevant qualifications and experience in of key personnel, including: the PI and other scientific leadership. Each team must provide expertise in multiple disciplines commensurate with the specific overarching goal of the proposed Center.

Section 3. Institutional Environment and Resources (up to 4 pages suggested). Document the commitment of all the participating institutions to support the proposed Center and respective consortium/subcontract arrangements. Describe the anticipated relationships and arrangements (e.g., space, personnel protected time, availability of common services and resources, etc.) between the proposed Center and other organizational units of the participating institutions (such as departments, centers, institutes, and central administrative units).

Avoiding duplication with the standard Resources form page, summarize unique research and/or developmental capabilities that will be available to the proposed Center.

Section 4. Center Organization, Leadership, and Administrative Core (up to 6 pages suggested). Summarize the organizational and decision-making structure of the proposed Center. Include organizational charts; describe the infrastructure, relation to the administrative structures of the host institutions (applicant and consortium/subcontracting institutions). Describe leadership plans.

Describe the organization and expected functions of the Administrative Core, including the roles and responsibilities of the principal investigator (PI), Task-Specific Project leaders, core directors, and participating investigators/collaborators.

Briefly describe the anticipated organizational relationship of the Center within the Network Describe the vision on how the Center will interact with the other Centers of the NTR. Applicants must acknowledge and agree in this section that awarded Research Centers will work jointly under the guidance of Steering Committee on the development and harmonization/standardization of methods for data collection and analysis across the different imaging platforms to be developed by each Center in the Network.

Applicants should describe their vision how their team may contribute to the Network-wide activities aimed at developing and testing generalized methods suitable for performance validation of multimodal imaging. Applicants should acknowledge their commitment to consider and implement SC recommendations for modifications of Primary Project and/or Developmental Task Project to accommodate new opportunities, needs, and developments. Also, applicants should anticipate publishing jointly with other centers and otherwise disseminating research findings and technological translational developments based on consensus approaches for the validation of imaging/spectroscopy methods. In addition, the participation of the PI and other selected investigators on the NTR Steering Committee should be described.

Section 5. Primary Project (up to 25 pages suggested). Describe the Primary Project following the standard PHS 398 instructions for Research Plan, Sections A-D. Define the Specific Aims of the Primary Project, and provide names and institutions of the lead investigator on each of the specific aims. The technical content of the Primary Project, along with methods for overcoming barriers to progress, must be presented in sufficient detail. Any preliminary data pertinent to the proposed project and supporting any feasibility claims and the chosen direction should be included in this section.

Section 6. Overall Description of Task-Specific Project(s) (up to 3 pages suggested).

Overall Description. Describe the process by which Task-Specific Projects will be administered as well as how their progress will be monitored during the course of the program. Also in this section describe the method by which future Task-Specific Projects will be formulated by the Center and procedures by which these projects will be selected for internal funding. Indicate how the Center will solicit, review, and select Task-Specific Projects. It is required that each Task-Specific Project supports one or more specific aims of the Primary Project. Therefore, the method of selection should include a discussion of how the value of the Task-Specific Project to a particular specific aim will be determined. It is expected that the selection process will involve some kind of peer review evaluation.

Task-Specific Projects to start Year 1 (Up to 4 pages for each Task-Specific Project suggested). Each team must define and describe the Task-Specific Projects planned to start in Year 1 of the program. Provide the title of the project, the name of the project leader, and the institution(s) in which the project will be performed. Provide names of other key personnel along with the percentages of effort. A typical Task-Specific Project is expected to cover from 3 months up to 2 years with direct costs comparable to those of R03 or R21 awards. Indicate which specific aims of the Primary Project each Task-Specific Project will support, and give an estimate of the duration of each listed Task-Specific Project.

Section 7. Research Support Cores (up to 4 pages suggested). Depending on the anticipated needs of the Center, applicants may propose one or more Research Support Core(s). Research Support Cores should be proposed as needed for the research program of a given applicant team. These Cores may eventually serve as a shared resource for the entire Network. The NTR Steering Committee will facilitate arrangements for projects in all Centers to have access to Core services over the entire Network. The applicant team should express their commitment to interface the Cores with other teams within the Network.

Research Support Core Discussion (additional allocation of up to 10 pages for all Research Support Cores). For each Core proposed, provide the Core title, name of Core director with affiliation, and names of other key personnel along with the percentages of effort. Each Core is expected to function for the full length (most likely 5 years) of the award.

The proposed Research Support Cores must not duplicate any available service facility/core already established in the applicant’s organizations and supported by other public funding sources (e.g., NIH P30, P41, P01, or U01 awards or DoD Congressionally-Mandated Medical Research Programs support, etc.). However, if appropriate, investigators are encouraged to propose supplementation of an existing resource/facility/core with funds and/or personnel effort in order to serve the needs of their program more efficiently. Such cross-affiliations, e.g., with existing Cores organized under other NIH grants, are encouraged to minimize cost duplication and reduce start-up time.

Foreign Organizations

Several special provisions apply to applications submitted by Foreign organizations and they are as follows:

Request budgets in U.S. dollars.
Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component). See NOT-OD-06-096, August 23, 2006.
Charge back of customs and import fees is not allowed.
U.S. Government grants cannot pay taxes in foreign countries, including VAT tax.
Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.

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.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

For details on what items are generally allowed as Appendix materials, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

Do not attach Appendix materials to the application. These materials must be submitted directly to the NCI, see Section IV. 3.B. Sending an Application to the NIH).

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times: Not applicable.

3.A. Receipt, Review, and Anticipated Start Dates

Letters of Intent Receipt Date: December 24, 2007
Application Receipt Date: January 24, 2008
Peer Review Date: June/July 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 2008

3.A.1. Letter of Intent

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

Descriptive title of proposed research;
Name, address, and telephone number of the PI;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.

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 institute or center (IC) staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document and above (Section IV.3.A).

Dr. Houston Baker
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, Room 6060, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852-7412 (for non-USPS express/courier delivery)
Telephone: (301) 594-9117
Fax: (301) 480-3507
E-mail: bakerhou@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for non-USPS express/courier delivery)

At the time of submission, two additional paper copies of the application and one copy of the appendix material in paper or pdf format must be sent to the address below (NCI encourages submission of Appendix materials in pdf format on a CD):

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-USPS express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefgrp@mail.nih.gov

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

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

3.C. Application Processing

Applications must be received on or before the application receipt date described at the beginning of this document and above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NCI. Incomplete and 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 http://grants.nih.gov/grants/policy/policy.htm.

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

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

6. Other Submission Requirements

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. This includes not only sharing data across the Network, but also with the broader research community. It is expected that as part of the Network, each Center will share data and results with other Center members on a regular basis. Data sharing will occur through regular SC teleconference meetings, semi-annual Network meetings, and other interactions of investigators involved.

Data sharing requirements will apply only to validation methods as defined in this FOA. The sharing of data and processes related to the development of imaging technology or probes/agents are not initially required.

The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients will make unique research resources readily available for research purposes to the other Center members of the Network and to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Research resources include those related to the validation of the proposed imaging platforms, as defined in this FOA, and include by way of example, open source software tools for data collection, analysis, or storage and display, methods for system validation including phantom design and construction, and data fusion methods for multimodal imaging. Investigators responding to this funding opportunity should include a plan for sharing research resources that address how unique research resources will be shared or explain why sharing is not appropriate.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by NCI Program staff when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review;
Availability of funds; and
Relevance to program priorities.

2. Review and Selection Process

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

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

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.

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, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

For this FOA, the novelty of concepts, approaches, and methods are secondary to translational research dedicated to combinations of imaging systems that would offer new clinical solutions. Strengths in translational approach, validation, and multimodal imaging integration are more relevant to this FOA than challenging existing scientific paradigms. In this context, reviewers will evaluate the overall merit of each application as well as the merit of its individual components: Primary Project, Development Tasks, Research Support Cores, and Organization & Administration using the following general (NIH-wide) criteria appended with aspects specific to this FOA. Reviewers will be asked to evaluate the integration and translation of the proposed multimodal imaging platform(s) as to how it advances the chosen clinical cancer imaging goal. In addition, they will evaluate the proposed plan to create consensus validation approaches, quality control and assurance methods, and standard operating procedures.

Significance: Does this study address an important clinical goal? 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, or preventative interventions that drive this field?

Specific to this FOA: Is the stated overarching goal clinically significant? Does this goal address an unmet need in cancer imaging? What will be the effect of the proposed research on advancing the general development of consensus approaches for optimization, validation, and translation of multimodal imaging platform(s) for targeted cancer applications?

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

Specific to this FOA: Is the proposed imaging platform appropriate for the chosen clinical cancer imaging goal? Are the Primary Project, Task-Specific Projects, and Cores integrated to create a complete program that will create a successful solution to the stated clinical cancer imaging goal?

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?

Specific to this FOA: Does the proposed imaging platform(s) represent an innovative combination of concepts, approaches, and/or methods in translational research? Will the proposed research facilitate consensus on methods for validation and translation, and widen their acceptance in the imaging research and industrial communities?

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)?

Specific to this FOA: Does the application demonstrate that the applicant team has the background expertise, leadership qualities and skills to collaborate in a multidisciplinary approach to develop and validate the proposed imaging platform(s)? Do they commit adequate effort to complete the project within 5 years? Do the applicants describe willingness to collaborate with other Centers to develop consensus on methods for validation of imaging platforms?

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?

Specific to this FOA: Do the applicants describe arrangements among participating institutions/groups ensuring optimal use of the technical potential of each Center component? Are tasks and responsibilities distributed according to technical skills and expertise across the proposed Center? Will the multi-site research environments of the proposed Center positively contribute to the goal of completing the development and validation of the proposed imaging platform(s) within 5 years?

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 priority score:

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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 evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resource sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. Important: The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in Item 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 NIH U54 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.

Throughout these Terms and Conditions of Award, Network for Translational Research (NTR or Network ) refers to all individual NTR awardees and comprises the organizational structure, which is composed of the individual awardee institutions, principal investigators (PIs) and other key personnel, all of whom agree to collaborate on research goals of the NTR.

2.A.1. Principal Investigator Rights and Responsibilities

Each Specialized Research Resource Center awardee will have primary and lead responsibilities for its Center projects as a whole, including research design and protocol development, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, as well as collaboration with other awardees in this Network.
The PI retains primary responsibility for the performance of activities supported by each award.
An awardee will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies, and consistent with the objectives of the NTR Specialized Research Resource Center.
An awardee has the responsibility to collaborate with other Centers of the NTR and participate in its Steering Committee (described under Section VI 2.A.3 Steering Committee) and implement SC recommendations.
Two members of each awarded Specialized Research Resource Center (one of whom must be the Principal Investigator) are required to serve as members of the Steering Committee. These representatives will collectively have one vote.
An awardee has the responsibility to provide the SC and the NCI with comprehensive information on the progress at their Center as described below (see Section VI. 3. Reporting).

2.A.2. NIH Responsibilities

The NCI will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NCI program staff scientists and directors, consisting of the Imaging Technology Development Branch Chief, Division of Cancer Treatment and Diagnosis (NCI) and two other scientific advisors from the NCI Cancer Imaging Program and Division of Cancer Prevention will serve as Project Scientists/Project Coordinators. The role of these individuals will be to advise, assist and facilitate, but not to direct the activities of the Network. Specifically, the NTR Project Scientists/Coordinators will:

Monitor the operation of the NTR and participate in the decisions of the Network by serving as a voting member on the Steering Committee (with only one vote in total for the NCI) and participating (as voting members) in subcommittees formed by the Steering Committee, as appropriate;
Make recommendations on overall project directions and allocations of project funds;
Coordinate and facilitate the interactions and information sharing among the individual PIs and participating institutions, and serve as liaison between the Steering Committee and the individual Centers;
Assist the Steering Committee in developing operating policies and procedures and assure that those policies are (a) acceptable to the NCI and (b) consistent with NIH policies and federal regulations;
Review the progress of individual Centers and specific activities shared among the Centers;
Participate as Collaborators in some shared activities, if appropriate; and
Assist the awardees as a resource in stimulating their broader interaction with other NCI and NIH programs to accelerate the translational research efforts toward clinical studies.

The NCI Project Scientists/Coordinators will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver according to the NCI procedures for management of conflict of interest if such participation is deemed necessary.

Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award. Program Official will attend Steering Committee meetings as a non-voting observer.

The NCI reserves the right to terminate or curtail an individual award in the event of insufficient progress, failure to adhere to policies established by the Steering Committee, or other major breach of NTR objectives.

2.A.3. Collaborative Responsibilities

A Steering Committee (SC) will be the main governing board for the NTR. The SC will be jointly established by all the awarded Centers (four are expected) and involved NCI staff members. The SC will consist of the following voting members

Two representatives from each awarded Center (one of whom must be the Principal Investigator), who will collectively have a single vote for each Center; and

Three designated NCI Program staff members serving as Project Scientists/Coordinators, who will collectively have one vote for the NIH.

In addition, the designated NCI Program Official will participate in the activities of SC as a non-voting member. Additional members (without voting rights) to serve in advisory capacity may be added to the SC 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., FDA, NIST, DoD).

The EC will elect one of the Center PIs as its chair for a 1-year term annually during the period of the program.

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

The EC will have primary responsibility for the overall organizational oversight of the NTR Network and for reviewing the research goals among the Centers. Responsibilities of the SC will include the following:

Review progress of each Center to make recommendations that encourage ~~inter-~~ ~~and~~ intra-Center collaborations to enhance progress and consensus on validation methods;
Review and facilitate the efforts aimed at sharing of validation methods across the Network;
Review the potential of Research Support Cores at the individual Centers to serve the needs of other Centers or the entire Network,
Plan agendas and participate in the organization of semi-annual NTR meetings;
Ensure that NTR Centers address their multimodal platform goals and clinical objectives;
Ensure that NTR takes advantage of resources provided by CaBIG, NCI Imaging Archive, and the XIP imaging workstation for interoperability of image and meta-data, and related open source tools.
Schedule and organize semi-annually meetings at which NTR Center members will present their scientific progress and future plans (these Center meetings need to coordinate with the SC meetings);
Schedule bi-monthly telephone conference calls to coordinate the activities of NTR;

Each awardee is required to submit a written annual report (Form 2590, see below) on research progress to NCI.

External Advisory Committee: An external advisory committee will be formed by the SC. It will consist of imaging and translational research experts from the academic community and from medical imaging and pharmaceutical companies,

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 PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. This report should include a comprehensive technical discussion of progress. In addition to this annual report, all awardees will submit the following reports to the SC according to the indicated schedule:

Mid-year progress report: This report is submitted to the SC annually, but 6 months after the required annual report to NCI (Form 2590). The technical section of this report should not exceed 5 pages, and is intended to highlight interim progress briefly. The Form 2590 can be used as a template for the mid-year report to the SC.
Core facility expense report: This report is to be part of the financial reporting in the Form 2590 and in the mid-year progress report. It is to show the planned expenses in each of the cores versus the actual expenses in each core.
List of publications and presentations: A list of publications, presented papers and poster sessions supported by this cooperative agreement will be submitted to the SC on a quarterly basis.
Publications: Copies of each Center publication supported by this grant will be sent to the SC upon acceptance by a journal.

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:

The NCI Program Director for this program is:
Dr. Houston Baker
Program Director
Cancer Imaging Program
Division of Cancer Diagnosis and Treatment
National Cancer Institute
6130 Executive Boulevard, EPN Room 6060, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852-4910 (for non-USPS delivery)
Telephone: (301) 594-9117
Fax: (301) 480-3507
E-mail: bakerhou@mail.nih.gov

Other NCI program contacts are:

Dr. Laurence Clarke
Chief, Imaging technology & Development Branch
Cancer Imaging Program
Division of Cancer Diagnosis and Treatment
National Cancer Institute
6130 Executive Boulevard, EPN Room 6066, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852-4910 (for non-USPS delivery)
Telephone: (301) 435-9190
Fax: (301) 480-3507
E-mail: lclarke@mail.nih.gov

Dr. Robert Nordstrom
Program Director
Cancer Imaging Program
Division of Cancer Diagnosis and Treatment
National Cancer Institute
6130 Executive Boulevard, EPN Room 6071, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852-4910 (for non-USPS delivery)
Telephone: (301) 594-9121
Fax: (301) 480-3507
E-mail: nordstrr@mail.nih.gov

Dr. Keyvan Farahani
Acting Chief
Image-Guided Interventions Branch
Cancer Imaging Program
Division of Cancer Diagnosis and Treatment
National Cancer Institute
6130 Executive Boulevard, EPN Room 6066, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852-4910 (for non-USPS delivery)
Telephone: (301) 451-2651
Fax: (301) 480-3507
E-mail: farahani@nih.gov

Dr. Guoying Liu
Program Director
Cancer Imaging Program
Division of Cancer Diagnosis and Treatment
National Cancer Institute
6130 Executive Boulevard, EPN Room 6062, MSC 7412
Bethesda, MD 20892-7412 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852-4910 (for non-USPS delivery)
Telephone: (301) 594-5220
Fax: (301) 480-3507
E-mail: liug@mail.nih.gov

Dr. Guillermo Marquez
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3066, MSC 7346
Bethesda, MD 20892-7346
Telephone: (301) 451-3896
E-mail: marquezg@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
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-USPS express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefgrp@mail.nih.gov

3. Financial or Grants Management Contacts:

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

Section VIII. Other Information

Required Federal Citations

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); and 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.

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

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

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

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: 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 2 years to the research. For further information, please see http://www.lrp.nih.gov.