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: Academic-Industrial Partnerships for Development and Validation of In Vivo Imaging Systems and Methods for Cancer Investigations (R01)

Announcement Type
New

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least 4 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-214

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

Key Dates
Release/Posted Date: February 12, 2007
Opening Date:February 12, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 6, 2010

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) will utilize the National Institutes of Health (NIH) Research Project Grant (R01) award mechanism to solicit applications from research partnerships formed by academic and industrial investigators to accelerate the translation of in vivo spectroscopic and imaging systems and methods into cancer research, clinical trials, and/or clinical practice. The partners on each application will establish an inter-disciplinary, multi-institutional research team for the purpose of advancing imaging technology development toward its application in human or animal studies as described below.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


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

Section III. Eligibility Information
1. Eligible Applicants

A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The overall goal of this Funding Opportunity Announcement (FOA) is to accelerate the transition of in vivo spectroscopic and imaging systems and methods into cancer research, clinical trials, and/or clinical practice. A related goal is to advance new technologies and methods for animal imaging. To promote these goals, the Cancer Imaging Program (CIP) of the National Cancer Institute (NCI) solicits applications from multi-institutional research partnerships formed by academic, industrial, and other investigators. The partners will establish an inter-disciplinary, multi-institutional research team for the purpose of developing imaging technology that is applicable to cancer research involving human subjects and/or animal models. The academic-industrial partnerships must be dedicated to the complete research and development cycle, culminating in the product prototype stage. The partnership model is expected to more readily overcome various barriers to the development of new imaging devices and technologies faced by either academia or industry working alone.

This FOA replaces two previous Program Announcements, PA-04-095 (http://grants.nih.gov/grants/guide/pa-files/PA-04-095.html), Novel Technologies for In Vivo Imaging (R21/R33), which expired on November 2, 2006, and PAR-03-157 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-157.html), Industry-Academic Partnerships for Development of Biomedical Imaging Systems and Methods that Are Cancer Specific (R21), which expired on November 18, 2004.

Background

Recent advances in the development of anatomical, functional, and molecular imaging methods are having a significant impact on clinical cancer research. Examples of pertinent fields include early cancer detection, screening, diagnosis, image-guided intervention, and therapy monitoring. The development and validation of the emerging imaging technologies and methods, however, are becoming increasingly complex. For example, there is a recent trend toward quantitative multi-modality imaging, in which the physical characteristics of one imaging system are used to improve the quantitative performance of another system. Multi-modality imaging systems, such as CT and PET, CT and SPECT, MRI and PET, or MRI and optical are being explored for their synergy in the medical imaging environment. The use of contrast agents or nano-carriers for transporting therapeutic agents adds complexity to the design, optimization, validation, and regulatory approval of fully integrated imaging systems. Because of this increased complexity, their effective implementation in multi-site clinical investigations and outcome research is often limited.

As clinical imaging systems become more complex, the assessment of their performance characteristics for clinical settings increasingly needs to be expanded beyond conventional factors (e.g., instrument signal-to-noise, and spatial or temporal resolution). Similarly, image acquisition, reconstruction, data processing and integration methods frequently need to be optimized and validated for specific clinical protocols that may include the use of contrast or therapeutic agents. As a result, integrated solutions are needed to develop emerging imaging devices, technologies, and improvements into useful clinical tools. The development and validation of the new and emerging imaging technologies/tools/approaches for clinical research and practice pose new problems that require broad expertise and resources to solve.

New imaging technologies and methods benefit not only clinical research and practice but also research conducted in animal models of human tumors. Advances in imaging tools may provide valuable ways to observe pathways of disease progression and therapeutic response in these models. For example, recent progress in genomics and proteomics, together with molecular imaging, are advancing our knowledge of the molecular basis of tumor biology. These emerging developments in basic cancer research offer new opportunities to expand the use of molecular imaging for: enhanced cancer detection and diagnosis; better accuracy needed to validate new cancer targets in proof of concept studies; improved patient selection and dose determination in drug development; and quantitative assessment of drug responses.

Important, cancer-relevant uses of animal imaging techniques include, for instance, studies of cell-cycle pathways, their manipulation and control, as well as various pharmacokinetic and pharmacodynamic endpoints for contrast and therapeutic agents (e.g., toxicity, uptake, bio-distribution, and clearance rates). Animal imaging technology platforms and methods face many of the same developmental and validation challenges as those for human investigations, as well as the challenges posed by their reduced scale.

Academic-Industrial Partnerships

This initiative is designed to encourage inter-disciplinary research teams from industry and academia to undertake development, modification, validation, and integration of imaging systems and methods for the purpose of advancing them into cancer research and clinical applications. The emphasis is on technology validation and integration of imaging systems and methods for the purpose of advancing cancer research using experimental animals and for cancer-relevant clinical applications. The prerequisite for the participation in this initiative is the formation of an appropriate multi-disciplinary team consisting of both academic and industrial scientists.

The reason for requiring inter-disciplinary, multi-institutional partnerships is to combine strengths unique to each group to accelerate the invention, development, and implementation of better imaging systems and methods. Academic investigators often focus on the discovery phase of an invention with the typical priorities set on the demonstration of feasibility (a proof of principle studies) and publication of their findings. The tasks of robust system engineering and validation studies that would eventually lead to a broader application and acceptance of the imaging technology by end-users in the medical community are usually considered to be part of product development process. Even though such developmental activities may be technologically challenging, they are rarely viewed as scientifically innovative. Similarly, the development of informatics infrastructure and interoperable informatics tools to support the application of new imaging methods is often not perceived as truly innovative by academic basic and translational researchers. In addition, the traditional academic and NIH grant reward systems often do not provide sufficient motivation for academic investigators to engage in the development of fully integrated solutions for biomedical imaging.

Industrial researchers may also experience barriers that discourage translation of an invention into practice and delivery of emerging imaging technologies to end-users. The expense of developing a new imaging device or technology must be evaluated within the larger context of return-on-investment before a company will commit to a new research project. Furthermore, commercial entities tend to avert risks associated with initiating development of emerging imaging methods with a high level of complexity. Industrial endeavors tend to put priority on modifications to existing imaging products that expand the utility of the imaging platform rather than on novel imaging principles and solutions. Industry often finds it more cost-effective to purchase intellectual property rights from academia, rather than to engage in a full laboratory development. Unlike the academic environment, industrial research facilities are typically well suited for product research and development (R & D) and for ensuring compliance with good manufacturing practice (GMP) standards, and strict International Standards Organization (ISO) requirements necessary for approval of their products by regulatory bodies (notably, by the Food and Drugs Administration [FDA]). Industrial environment alone, however, may not be most conductive for inventing new technologies.

This FOA is designed to overcome the limitations of a traditional structure, in which the academic scientists come up with a novel idea and provide proof-of-concept experiments, but then turn to the industrial scientists for any further technology development/validation and final product engineering. Academic-industrial partnerships that begin with the conceptual phase and continue for the duration of the project are one approach for reducing barriers faced by both academic and industrial researchers.

Partnerships expand access to a range of resources and facilitate problem-solving from initiation through validation, Federally required approval process, to market delivery and clinical use. For example, technology testing and validation often require specialized animal research facilities and/or clinical settings with patients and clinical expertise. These resources are common in many academic settings, but unusual for most industrial environments. Moreover, by establishing the academic-industrial team at the outset of the program, combined diverse expertise and points of view of the participants become a unique resource that may considerably facilitate and accelerate solving diverse problems associated with the inception and development of new ideas.

Specific Objectives

This FOA uses the R01 mechanism to encourage applications from academic-industrial research partnerships for projects that can and should be completed in 5 or fewer years.

The co-participation of academic and industrial components is expected from year one of the project. Each application must reflect an academic-industrial partnership that is either already ongoing or will be active from the beginning of the project. All the partnering institutions will be required to collaborate on the proposed goals in a manner that would enable the entire joint effort to be administered as a single project. Each partner should have sufficient scientific involvement and at least one participating investigator who would qualify as a PI and who will share authority and responsibility for leading the project.

Academic-industrial partnerships responding to this funding opportunity may choose to develop/optimize/validate/integrate imaging systems, component technologies and/or methods that will lead to clinical utility or will advance imaging tools in cancer research using experimental animals. To be responsive to this FOA, the proposed research must emphasize the transitioning of imaging systems or methods from the laboratory into either the clinical environment or the imaging domain applicable to experimental animal research. In addition, a priority is on imaging methods and systems for which some level of feasibility has already been established but for which expanded efforts are needed to validate this feasibility and to develop useful imaging tools for the clinical environment and/or for animal research.

If performance in the clinical environment is the chosen end-point of the proposed research, the application should clearly address the projects clinical significance. Teams proposing such projects should include as key participants imaging physicians, oncologists, and other clinical scientists as appropriate to specific research plans. Clinical studies may be proposed to establish the functionality of the development, clinical promise, optimization, and validation of new or improved imaging tools. However, large-scale clinical trials are beyond the scope of this FOA and applications proposing large clinical trials are not appropriate. .

Research plans must be structured so that by the end of the funding period the imaging systems and methods developed will reach a level of maturity and validation to support implementation of multi-site preclinical and clinical investigations or clinical trials.

Examples of research directions involving imaging. The research directions of clinical or animal imaging may include pre-cancer or early cancer detection, cancer screening, diagnosis, image-guided intervention, and monitoring of treatment response. The following list includes some examples of clinical in vivo imaging and animal imaging applications that address the cancer problem. Examples include, but are not limited to, research applications for development and validation of imaging platform(s), system(s), and method(s) for:

Examples of imaging technologies/methods. Possible technologies and methods to develop and validate under this FOA include, but are not limited to, the following:

Examples of imaging-related research resources/tools. The research team may engage in the development of research resources during the course of their research program. For example, these research resources may serve as a means to standardize methods for image quality control, data collection and analysis for human or animal investigations across different commercial imaging platforms. Specific tools may include, but are not limited to, the following:

Support for collaborative activities. In order to meet the objectives of the partnership program, permitted collaborative activities of both academic and industrial investigators may include the following:

Beyond the scope of this FOA, additional collaborative activities are encouraged with an existing NCI-funded center or consortium (i.e., with U01, U54, U24 awardees), as pertinent to a broader consensus for the proposed translational research methods or the creation of public research resources for translational research.

Alternative funding opportunities for imaging-related research. Investigators pursuing imaging research that is beyond the scope and requirements of this FOA may refer to the following other FOAs:

Bioengineering Research Grants (BRG) [R01] (PA-06-419) http://grants.nih.gov/grants/guide/pa-files/PA-06-419.html

Bioengineering Research Partnerships (BRP) [R01] (PAR-06-459) http://grants.nih.gov/grants/guide/pa-files/PAR-06-459.html

In Vivo Cancer Imaging Exploratory/Developmental Grants [R21] (PA-06-371) http://grants1.nih.gov/grants/guide/pa-files/PA-06-371.html

Quick-Trials for Novel Cancer Therapies: Exploratory Grants [R21] (PAR-06-451) http://grants.nih.gov/grants/guide/pa-files/PAR-06-451.html

Quick-Trials for Imaging and Image-Guided Interventions: Exploratory Grants [R21] (PAR-06-293) http://grants.nih.gov/grants/guide/pa-files/PAR-06-293.html

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism.

The applicants will be solely responsible for planning, directing, and executing the proposed project.

Applications should propose a project that can be completed in 5 or fewer years.

This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

2. Funds Available

The applicants may request R01 budget periods of up to 5 years. The amount of funds requested and their distribution between years should be tailored to the needs of the project, usually less than $500,000 in total direct costs in any one year of the project excluding third party indirect costs.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The awards made under this FOA are non-renewable.

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Partnerships eligible to apply in response to this FOA must include at least one academic institution and at least one for profit (industrial) institution.

With this general provision met, you may submit an application(s) if your institution/organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.

To demonstrate and facilitate the partnerships, projects proposed in response to this FOA are strongly encouraged to involve at least two PD/PIs; one representing the academic component and the other representing the industrial component, respectively. Furthermore, applicants may choose to designate additional PD/PIs for each of the partnering components/institutions. The decision of whether to designate additional multiple PD/PIs from each partnering institution is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. In the leadership plan, the applicants may designate one PI as an overall coordinating PI.

Since the applications in response to this FOA are expected to have at least two PDs/PIs, these applicants will have to follow the special procedures for multiple PD/PIs and consider additional factors outlined below and described in detail in Section IV.2 Content and Form of Application Submission.

Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, and, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different from any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone: 301-435-0714; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

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

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

Applications from foreign organizations must:

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 U.S. or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications Involving Multiple Institutions

Applications in response to this FOA will always involve at least two institutions. When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

Applications with Multiple PDs/PIs

Applications in response to this FOA are expected to involve at least two PD/PIs representing the academic component and the industrial component. When multiple PDs/PIs are involved, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Depending on the leadership plan, applicants may designate one of the PIs from either academic or industrial component of the partnership as a coordinating PI. It is expected that the coordinating PI, who will oversee the integration of all components and task coordination among participating institutions, will be based at the prime institution of the application. The same individual designated as coordinating PI may also be designated as Contact PI.

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.

All applications involving Multiple PDs/PIs are required to include a new section describing the leadership of the project.

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

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:February 12, 2007 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization)on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have 2 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal (formerly 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 renewal award.

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

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

Item 3 of the PHS398 Research Plan is limited to 12 pages.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Additional Special Instructions for Preparing Partnership Applications

1. PHS398 Cover Letter component. Applications should be submitted with a cover letter that lists the project title, partnering institutions, PI/PD designated on behalf of each partner, and the overall Coordinating PI (who may also be the Contact PI).

2. Research Plan must be consistent with the instructions in the SF424 (R&R) Application Guide but should also address the following:

a. Significance. Describe how the proposed research will facilitate implementation of an advanced imaging technology, methods, and/or tools into animal studies or clinical use and how these outcomes will accelerate early detection, screening, diagnosis, or treatment of cancer. Investigators must show the importance of the proposed work with respect to the background of the field, and how their proposed research will advance scientific knowledge to address the cancer problem.

b. Preliminary Studies for New Applications and Progress Reports for Renewal and Revision Applications. Scientifically sound preliminary data or information relevant to the proposed collaboration should be included to aid review, if available. Applicants should also describe the experience of their group in collaborative programs and activities with partners in academia and industry.

c. Partnership Plan. All applications must include in the Approach section a specific sub-section describing the overall organization of the partnership, the major tasks to be completed by each partner, and the anticipated benefits including an assessment on how the partnership enhances the feasibility of the completion of the specific aims proposed. The roles of both academic and industrial partners and shared administrative, technical, and scientific responsibilities for the project should be delineated.

Note: Assuming that the multiple PD/PI model is used, the details on the roles of individual PIs, the governance organizational structure of the leadership team, communication plans, process for making decisions on scientific direction, and procedures for resolving conflictsare NOT to be described here but in Multiple PD/PI Leadership Plan (Section14 of SF424 application) following the standard instructions.

If the multiple PD/PI model is NOT used, the Partnership Plan should also describe the overall governance and leadership structure, details of task coordination, including communication among participating researchers and organizations, process for making decisions regarding scientific directions, allocating resources, publications of the results, and procedures for resolving conflicts.

The technical details of the partnership plan and related resources should be addressed in Section 12 Consortium/Contractual Arrangements (see below). Plans on intellectual property (IP) sharing are not required for this submission. However, if such agreements are available, they can be mentioned in this section to aid in review. All other partnership agreements between academia and industry will be the responsibility of all the stakeholders in the proposed application and will not be part of the NIH review process described below.

d. Benchmarks/Timelines. To facilitate the assessment of the chances for successful completion of the proposed project, applicants should describe in Approach section quantitative benchmark parameters and offer a timeline for the development of the proposed product/technology.

e. Consortium/Contractual Arrangements (Section 12). Use this section of the application to discuss specific details of the partnership plan mentioned above. Organization charts, Gantt charts, or other visual aids that help to present the methods by which the partnership will solve technical and translational research problems in a timely manner are encouraged.

f. Multiple PD/PI Leadership Plan (Section14) Since applications are expected to have at least two PDs/PIs, a section of the research plan, entitled Multiple PD/PI Leadership Plan, should be included. This section may identify a coordinating PI and should define the roles of all the PIs in the overall project leadership (complementing the information in sub-section on Partnership Plan, under Approach section).

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component.See Section 3.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets.

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

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

1) Contact the NCI program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

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

3) Include the PHS398 Cover Letter component with the application to identify the staff member of the NCI who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly competing continuation) applications, resubmission (formerly revised/amended) applications, and revision (formerly competing supplemental) applications. See NOT-OD-02-004, October 16, 2001.

APPENDIX MATERIALS

IMPORTANT NOTE: 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

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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

Foreign Applications (Non-domestic (non-U.S.) Entity)

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs for the entire project in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

Applicants requesting no more than $500,000 in direct costs in all years of the proposed research are encouraged to follow the spirit of data sharing.

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 Statementat http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). 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.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization 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). See Section VI.3., Reporting.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

A Special Emphasis Panel convened by the Center for Scientific Review in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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

The 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 impact/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.

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

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

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

Does the proposed partnership and research plan address translational research and provide imaging systems, methods, or research resources as required for the advancement of clinical research or support a broad range of small animal investigations?

Does the proposed partnership utilize the unique skills and capabilities of both academic and industrial partners in a complementary way? Does the proposed partnership structure adequately support the conduct of the translational research pertinent to human or animal imaging applications?

Investigator(s): Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers? Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project?

Is there evidence that the partners from academia and industry can work together effectively?

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

Does the proposed translational research address an unmet need of cancer imaging systems and methods in animal and human investigations? (Note: Novelty of the proposed research methods is of secondary importance to this FOA.)

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

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

Does the academic and industrial institutional support and research infrastructure demonstrate adequate commitment to this project?

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 impact/priority score:

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

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

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

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

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.

Additional Review Considerations

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

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

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

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

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



Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The impact/priority score should not be affected by the evaluation of the budget.

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the impact/priority score. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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 Statementat http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). 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 resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization 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). See Section VI.3., Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

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 NIH eRA Commons.

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

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

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

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 Contact(s):

Guoying Liu, Ph.D.
Imaging Technology Development Branch
Cancer Imaging Program
National Cancer Institute
6130 Executive Plaza, EPN Suite 6000, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-9531
Fax: 301-480-3507
E-mail: guoyingl@mail.nih.gov

Robert Nordstrom, Ph.D.
Imaging Technology Development Branch
Cancer Imaging Program
National Cancer Institute
6130 Executive Plaza, EPN Suite 6000, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-9531
Fax: 301-480-3507
E-mail: nordstrr@mail.nih.gov

Houston Baker, Ph.D.
Imaging Technology Development Branch
Cancer Imaging Program
National Cancer Institute
6130 Executive Plaza, EPN Suite 6000, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-9531
Fax: 301-480-3507
E-mail:bakerhou@mail.nih.gov

Keyvan Farahani, Ph.D.
Image-Guided Intervention Branch
Cancer Imaging Program
National Cancer Institute
6130 Executive Plaza, EPN Suite 6000, MSC 7412
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-9531
Fax: 301-480-3507
E-mail:farahank@mail.nih.gov

James A. Deye, Ph.D.
Radiation Research Program
National Cancer Institute
6130 Executive Plaza, EPN Suite 6015A, MSC 7440
Bethesda, MD 20892-7412 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-6111
Fax: 301-480-5785
E-mail:deyej@mail.nih.gov

2. Peer Review Contact(s):

Xiang-Ning Li, MD, PhD
SRA, Surgical Sciences, Biomedical Imaging and Bioengineering IRG
Center for Scientific Review / National Institutes of Health
6701 Rockledge Drive, Rm 5112 MSC 7854
Bethesda, MD 20892-7854
Tel: 301.435.1744
Fax: 301.451.5317
Email: lixiang@csr.nih.gov

3. Financial/Grants Management Contact(s):

Eileen M Natoli
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7800
Fax: (301) 496-8601
E-mail: natolie@gab.nci.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) 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 for the entire project 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 institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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, Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

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

NIH Public Access Policy:
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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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

The 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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