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: Centers of Cancer Nanotechnology Excellence (CCNEs)(U54)

Announcement Type
This is a reissue of RFA-CA-05-024

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

Request For Applications (RFA) Number: RFA-CA-09-012

Catalog of Federal Domestic Assistance Numbers
93.393, 93.394, 93.395, 93.399

Key Dates
Release Date: May 29, 2009
Letters of Intent Receipt Date: September 14, 2009
Application Receipt Date: October 14, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: September 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: October 15, 2009

Due Dates for E.O. 12372

Not Applicable

PRE-APPLICATION MEETING

The NCI anticipates holding a pre-application meeting on Thursday, July 23, 2009 at 2 pm EST to which all interested prospective applicants are invited. NCI program and review staff members will make presentations to explain the goals and objectives for the NCI Alliance for Nanotechnology in Cancer and Centers of Cancer Nanotechnology Excellence (CCNEs), to discuss the application peer review process, and to answer questions from the attendees.  An NCI Grants Management Specialist will be available to answer financial questions.  The meeting will take place on NIH main campus in Natcher Building (Bldg. 45), Room F1/F2. The meeting will also be videocast with an opportunity for internet viewers to submit questions by e-mail.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The overall purpose of this funding opportunity announcement (FOA) is to advance rapidly new nanotechnology discoveries and their transformation into cancer-relevant applications with clinical utility. To address this goal, applications are solicited for Centers of Cancer Nanotechnology Excellence (CCNEs).

CCNEs will provide the main research infrastructure for the NCI Alliance for Nanotechnology in Cancer program (first established in 2004; http://nano.cancer.gov). Within the Alliance, CCNEs will serve as a national resource assembled to develop research capabilities and programs enabling multi-disciplinary team research advancing cancer prevention, detection, diagnosis, and/or treatment. In addition to strong, integrated research programs, these centers will also provide shared research support resources and other shared resources. It is expected that, as a part of the Alliance, CCNEs will ultimately generate novel preventive, diagnostic, and therapeutic approaches to modulate and overcome cancer processes in ways and areas that are currently not available and cannot be realized using existing state-of-the-art technologies.

This FOA will support a network of CCNEs for the research and development of cancer-oriented techniques and tools based on nanotechnology, including the completion of the pre-clinical stage of development of nanotechnology-based solution to the clinically relevant cancer problem(s). Even though clinical trials are beyond the scope of this FOA, all CCNEs must be strongly committed to and capable of further translation of the technologies/tools under development. Therefore, specific research programs and efforts proposed by all CCNE applicants must be oriented on generating outcomes that will pave the way to clinical trials. CCNE applicants are strongly encourage to plan to proactively seek other sources of funding that would allow for clinical trials shortly after the completion of the CCNE award (or even during the award period).

To maximize the likelihood of generating a clinical trial-ready product/tool/technology and to facilitate its rapid commercialization, all proposed CCNEs are expected to include a meaningful participation of for-profit organizations from the beginning. It is also expected that all the awarded CCNEs will take advantage of appropriate NCI resources such as the Rapid Access to Intervention Development (RAID) program, and the services of the NCI’s Nanotechnology Characterization Laboratory (NCL). In addition, CCNEs interaction with the NCI Clinical Translation Evaluation Program (CTEP) and clinical trial programs is expected to facilitate further the translation into the clinic of the nanotechnological solutions to be developed. In addition, CCNE applicants are encouraged to take into account the NCI strategic position on efficient translational research that is summarized in a comprehensive report of the NCI Translational Research Working Group (TRWG) (http://www.cancer.gov/trwg).

To build multidisciplinary teams needed for the goals of this FOA, each proposed CCNE must provide leadership in medicine/biological sciences as well as in the fields of chemistry, physics, or engineering. Therefore, applicants are expected to take advantage of the multiple Program Directors/Principal Investigators (PDs/PIs) option. Each proposed CCNE is expected to have a leadership structure in which one senior investigator (PD/PI) is identified to lead the area of clinical translational oncology and another investigator (PD/PI) is identified to lead the efforts in the area of applied nanotechnology.

Definition of nanotechnology in the context of this FOA. For the purposes of this FOA, applicants are encouraged to use the National Nanotechnology Initiative (NNI); http://nano.gov/html/facts/whatIsNano.html definition as a guideline. Specifically, to be responsive to this FOA, the proposed research projects (and materials/technologies/devices involved) must meet the following criteria:

1) Devices or base materials must be smaller than 1000 nm in size although the assembly, synthesis, and/or fabrication of components of these final structures at dimensions less than 300 nm should be demonstrated;

2) Devices/materials used and/or proposed to be developed must be either (a) synthetic materials or (b) biomaterials engineered to provide novel properties or modified functions based on nanoscale size, i.e., nanomaterials.

Non-responsive: Projects that propose only the use of naturally-occurring materials (e.g., carbohydrates, proteins, viruses) that are not specifically engineered or modified for a biomedical application will not be considered. Furthermore, projects focused primarily on genetic engineering or gene therapy (e.g., DNA sequencing or gene vector methods) are not appropriate for this FOA.

In addition, this FOA will NOT support clinical trials or in vivo studies in human subjects.

Background

Potential of nanotechnology in oncology. Nanotechnology belongs to the category of so-called “disruptive technologies”, i.e., innovations that are capable of breaking existing barriers and offering previously unexpected benefits. In the cancer context, nanotechnology can lead to a generation of new diagnostic and therapeutic products, resulting in dramatically improved cancer outcomes. The NCI explores various innovative approaches to multi-disciplinary research allowing for a convergence of molecular biology, oncology, physics, chemistry, and engineering and leading to the development of clinically-worthy technological approaches. These initiatives include programmatic efforts to enable nanotechnology as a driver of advances in clinical oncology and cancer research known collectively as the NCI Alliance for Nanotechnology in Cancer (http://nano.cancer.gov). The Alliance was founded in 2004 and is committed to developing and applying nanotechnology to cancer prevention, detection, diagnosis, and treatment.

Three strategic workshops to discuss cancer nanotechnology, its to-date accomplishments and future potential in oncology were conducted in 2008. The participants: clinicians, cancer researchers, and technologists echoed a clear consensus that cancer nanotechnology had made very significant advancements over the past three years, both in fundamental discovery and the development of practical, clinically-relevant solutions. The field of cancer nanotechnology has excellent potential for developing innovative ways to diagnose the disease at its early stages, using both in vitro assays and novel imaging methods. This field is also well positioned to provide improved methods for therapy as well as monitoring of therapeutic efficacy. It is expected that, in the future, nanotechnology will become a core component of research and translational programs at all leading cancer research institutions and a significant part of comprehensive cancer care.

How to facilitate nanotechnology development and implementation? The potential for transformative impact warrants continued support for research programs employing nanotechnology for the detection and treatment of cancer. There are, however, various barriers that need to be overcome to ensure efficient translation of laboratory discoveries to clinical trials and, ultimately, to clinical practice. The NCI identifies the following significant and specific needs to address:

Current nanotechnology-oriented efforts at the NCI. The NCI Alliance for Nanotechnology in Cancer program addresses the bulk of the identified needs. The continued Alliance program will consist of the following components:

  1. Centers of Cancer Nanotechnology Excellence (CCNEs). The multi-disciplinary CCNE teams (funded through this FOA) are expected to be the main venue for the discovery and tool development towards the prospective applications of nanotechnology in clinical oncology. CCNE teams will be required to focus on the integrated technology solutions, which have practical clinical applications and to pursue aggressive development of these solutions to the pre-clinical stage as well as provide a path to clinical translation. It is also expected that students and post-doctoral fellows working within CCNE structures will be immersed in the educational multi-disciplinary environment contributing to shaping their knowledge and future careers. Each funded CCNE will have a training/educational module.
  2. Cancer Nanotechnology Platforms. Smaller circumscribed nanotechnology projects with high transformative potential for basic and/or pre-clinical cancer research will be funded under “platform” awards (U01 funding mechanism, RFA-CA-09-013).  A separate FOA will be issued soon to solicit applications for platform awards.
  3. Interdisciplinary nanotechnology training and career development. Achieving the envisioned progress will require systematic efforts to train a cadre of researchers who are skilled in applying the tools of nanotechnology to critical problems in cancer research and clinical oncology.  Dedicated training- and career development-oriented FOAs (for R25 and K99/R00 funding mechanisms, respectively) will be issued to further accelerate and intensify the development of a workforce highly skilled in nanotechnology research.

The Alliance will also be directly supported by the following NCI efforts:

  1. Nanomaterials characterization. The NCI recognizes that further development of nanotechnologies for oncology purposes will benefit greatly from a concerted and coordinated effort to characterize the wide range of nanoscale materials and devices. The collection of this information will chart the common baseline and scientific data that would inform the research and development (R&D) community and define clinical and commercial pathways for integration of nanoscale diagnostics, imaging agents, and therapeutics. The NCI’s Nanotechnology Characterization Laboratory (NCL; http://ncl.cancer.gov) will provide infrastructure support towards the uniform and consolidated characterization of these materials and devices and thus will aid the translation of nanotechnology-derived cancer therapeutics and diagnostics from the advanced discovery-phase to clinical environment. Moreover, the information acquired in these studies will be linked to the network of Comprehensive Cancer Centers and related programs through public databases available through the NCI Center for Bioinformatics (http://ncicb.nci.nih.gov/).
  2. Nanotechnology-related informatics. The NCI Center for Bioinformatics (http://ncicb.nci.nih.gov/) sponsors the cancer Nanotechnology Laboratory portal (caNanoLab) https://wiki.nci.nih.gov/display/ICR/caNanoLab. caNanoLab is designed to enable sharing of nanotechnology data and to expedite and validate the use of nanoparticles in biomedicine.

Research Objectives and Requirements for CCNEs

The main objectives and expectations for each CCNE and the entire CCNE initiative include the following aspects:

Areas of Research Focus. In accordance with the principles of the Alliance, the NCI has identified three broad thematic/programmatic areas of focus for this FOA:

Area 1.  Early diagnosis using in vitro assays and devices or in vivo imaging techniques;

Area 2.  Multifunctional nano-therapeutics and post-therapy monitoring tools; and

Area 3.  Devices and techniques for cancer prevention and control.

The proposed CCNEs should have a primary focus on one of these areas, or possibly two, but with certain restrictions.  Specifically, a combined focus on Areas 1 and 2 is NOT appropriate, however  combination of Areas 1 and 3 or Areas 2 and 3 is permissible.

In each of these thematic/programmatic areas, a variety of specific research directions can be pursued. Examples of potential applications for each of the broad areas are listed below. Many of these examples have emerged from the strategic cancer nanotechnology workshops carried out by NCI in 2008 (the workshops’ reports can be found at http://nano.cancer.gov/meetings_events/Strategic_Workshops_on_Cancer_Nanotechnology_-_CancerRes_final_.pdf). Nonetheless, these examples are not meant to be comprehensive. Additional topics are encouraged providing they fit into the general scope of thematic/programmatic areas and are consistent with the NCI's overall goals for cancer nanotechnology. In addition, the topics are not mutually exclusive.

Tumor Types. Regardless of the broad area of focus or topical area considered for the development toward ultimate application in clinical care, all CCNE applicants are strongly encouraged to concentrate their efforts on two different tumor types, with a preference for those organs in which the disease is characterized by low survival rates. In particular, applications oriented on brain, lung, ovarian, and pancreatic cancers are encouraged.

Details on the three thematic/programmatic areas of focus for cancer nanotechnology and examples of potential research directions:

Area 1.  Early diagnosis using in vitro assays and devices or in vivo imaging techniques. Novel nanotechnologies can complement and augment existing genomic and proteomic techniques to analyze variations across different tumor types, thus offering the potential to recognize early the onset of the disease with sensitivity and specificity, which is not currently possible. Sensitive biosensors constructed of nanoscale components (e.g., nanocantilevers, nanowires, and nanochannels) can recognize genetic and molecular events and have reporting capabilities. These assays and devices, developed initially for in vitro use, can be later introduced to an in vivo environment to operate in the immediate proximity of the tumor for improved sensitivity of detection. The imaging contrast agents based on nanotechnologies (e.g., optical, magnetic resonance, ultrasound) are expected to be capable of identifying tumors that are significantly smaller than those detected with current technologies. When developed in conjunction with nanoparticle carriers and specific targeting ligands, these methods can improve tumor accumulation of the contrast agent and thus increase signal intensity and spatial resolution. Furthermore, imaging agents that target changes in the environment surrounding tumor (e.g. angiogenesis, pH changes, enzymatic environment) can further augment detection methodologies.

Examples of specific research directions for Area 1

Area 2.  Multifunctional nano-therapeutics and post-therapy monitoring tools. Because of their multifunctional capabilities, nanoscale devices can contain both targeting agents and therapeutic payloads - features useful in drug delivery to areas of the body that are difficult to access because of a variety of biological barriers, including those developed by tumors. Thus, multifunctional nanoscale devices offer the opportunity to utilize new approaches to therapy - “smart” nanotherapeutics may provide clinicians with the ability to locally deliver the drug at lower doses, while maintaining high efficacy or time the release of an anticancer drug or deliver multiple drugs sequentially in a timed manner or at several locations in the body. Such nanotherapeutics could also house engineered cellular “factories” that make and secrete proteins and other antigrowth factors that impact a tumor and/or its immediate environment. Nanotherapeutics can be also combined with imaging agents to provide indicators of drug accumulation in the technology development phase. Post-therapy monitoring is another area to consider for nanotechnology applications. The assessment of therapeutic efficacy is not always straightforward and often requires complex and time-consuming procedures. Nanotechnology devices and tools can provide new techniques to perform these post-therapy tests in in vitro and in vivo environment in a faster manner that is better tailored to the individual patient.

Examples of specific research directions for Area 2

Area 3.  Devices and techniques for cancer prevention and control. Nanotechnology can play a vital role in establishing novel approaches to the disease’s prevention. For example, nanoscale devices may prove valuable in delivering or mimicking polyepitope cancer vaccines that engage the immune system or cancer-preventing nutraceuticals or other chemopreventive agents in a sustained, timed-release, and targeted manner. Nanotechnology can also enable techniques allowing for effective disease management and elimination of cancer spread to other organs.

Examples of specific research directions for Area 3

A CCNE application may be entirely focused on cancer prevention and control (i.e., Area 3). However, many of the nanotechnology advances in therapeutic and diagnostic directions (Areas 1 and 2) may also be applicable in cancer prevention and control efforts. In such situations, proposed CCNEs may have a combined focus on two areas (Areas 1 and 3 or Areas 2 and 3).

Required Structure and Main Components of the CCNEs

All CCNE applicants must address the following main aspects for the proposed CCNE (for details see Section IV. Content and Form of Application Submission):

1.     Overall Research Focus. Each application must be focused on clinically-worthy technology solutions corresponding to one or possibly two (depending on the area(s) selected) of the three thematic/programmatic areas of focus as outlined above. Nanotechnology-based tools, techniques, devices and/or materials must meet the criteria for nanotechnology as defined in this FOA.

2.     Research Team. Each team must represent appropriately diversified backgrounds (medicine, biology, chemistry, physics, engineering), as needed for the scientific profile of the proposed CCNE. The group must be capable of and willing to work jointly as a multi-disciplinary team. Meaningful participation of a for-profit entity is strongly encouraged and expected for all the proposed CCNEs to elevate the chances for successful and rapid translation of the outcomes to the clinical settings and the ultimate commercialization potential. The team must provide full expertise necessary to complete the proposed basic research and translational projects (as needed in: clinical oncology, molecular biology, chemistry, physics, materials science, biomedical engineering, computational science, and mathematics). Involvement of basic and clinical scientists and engineers who may not have a specific record in cancer research, but who possess the potential to provide experience crucial to the success of the CCNE, is encouraged.

3.     Leadership and Organization of the Proposed CCNE. Applicants are strongly encouraged to designate multiple Program Directors/Principal Investigators (PDs/PIs). In the proposed leadership structure, one investigator (PD/PI) should be identified to lead clinical translational oncology and another investigator (PD/PI) to lead applied nanotechnology (with expertise, e.g., in the fields of chemistry, physics, or engineering, as appropriate for the specific CCNE). Each CCNE will be a “virtual” center comprising several laboratories and research facilities that may be physically located at various sites throughout the country or the world.  Participating institutions/organizations may be a mix of several academic, other non-profit, and/or for-profit entities, as needed. Nevertheless, the NCI recommends limiting the number of separate institutions involved as participants in one CCNE to no more than four entities. To facilitate effort coordination within the proposed center and across the Alliance, each CCNE must organize an Administrative Core as a shared resource.

4.     Research Program. A well-developed research program designed around one (or possibly two) of the specific thematic/programmatic areas discussed above will form the core of the application and should be integrated with other components. Thus, each team proposing a CCNE needs to demonstrate in-depth expertise in clinical oncology, cancer biology as well as in non-biological (e.g., engineering) aspects of the proposed research activities. Applicants must clearly describe in their applications how the newly developed nanotechnologies will address significant existing problems of cancer biology and what clinical utility applications these nanotechnologies can support. Emphasis should be placed on demonstrating why the proposed concepts and approaches are revolutionary within the context of related research and how the expected product/results will overcome currently existing barriers and knowledge gaps. The proposed research program should have the following attributes.

5.     Education/Training and Outreach Programs. A training program dedicated to the development of a new cadre of cancer nanotechnologists and a program to disseminate research findings and data sharing are mandatory components for all CCNEs.

6.     Developmental Projects and Trans-Alliance Activities. Each proposed CCNE must include plans for the development of Pilot projects (to be conducted within the Center), “Alliance Challenge” projects (involving collaborations with other Alliance awardees), and for other trans-Alliance activities.

Note: This FOA will not support clinical trials or in vivo studies in human subjects. However, in vitro investigations that employ clinical biospecimens or the theoretical modeling of human systems are within the scope of activities that will be considered for support by this initiative.

Targets for CCNE research (and beyond): it is expected that by the end of the project period, CCNE awardees will have completed all preclinical stages of technology development needed to secure approvals for clinical trials. Thus, it is also expected that successful CCNE awardees will seek and secure other funding to pursue vigorously clinical trials for technologies to be developed under the CCNE awards. For example, such continued efforts could be supported through partnerships with other groups and divisions within NCI. Among others, close interfaces with translational programs such as Rapid Access to Intervention Development (RAID), Clinical Translation Evaluation Program (CTEP), and clinical trial programs, as well as the use of services of Nanotechnology Characterization Laboratory (NCL) will provide viable assistance in this process.

Beyond the Alliance and other NCI resources, CCNE applicants are strongly encouraged to take advantage of the range of additional existing opportunities in nanotechnology research and development through partnerships with other Federal agencies, such as the National Science Foundation (NSF); http://www.nsf.gov and the Department of Energy (DOE); http://www.energy.gov. Crosscutting national nanotechnology initiatives such as the NSF Nanoscale Science and Engineering (NSE); http://www.nsf.gov/home/crssprgm/nano/start.htm; http://www.nsf.gov/pubs/2004/nsf04043/nsf04043.htm and the DOE Nanoscale Science Research Centers (NSRCs); http://www.sc.doe.gov/bes/BESfacilities.htm offer opportunities for partnerships commensurate with those expected from the CCNEs. The NSF and DOE programs are components of the National Nanotechnology Initiative (http://www.nano.gov/), a multi-agency framework of nanotechnology research that may serve as a resource for applicants to this RFA.

Governance of the NCI Alliance for Nanotechnology in Cancer

The Alliance, including CCNEs, will be governed by the Alliance Coordinating and Governance Committee (CGC).  The CGC will oversee and coordinate the activities of all CCNEs, platform awardees, and training centers. Details on the composition and functions of CGC are provided in Section VI.2.A.3, Terms and Conditions of Cooperative Agreement “Collaborative Responsibilities”.

Evaluation of the Program

As the efficiency of the funded research is an increasing priority for NCI, CCNEs will be required to participate in an external evaluation process of the Alliance initiative coordinated by NCI Program Staff. Outcomes to be assessed will include: peer-reviewed publications, patent disclosures and filing, technology commercialization, technologies brought to clinical trials, educational and outreach programs, and effectiveness of collaborative research development model. The purpose of the evaluation process is to monitor and assess the performance of the CCNEs in achieving the goals of this FOA. This component includes evaluating the quality and innovation of the research conducted at the CCNEs, as well as assessing critical intermediate determinants of the overall success, such as infrastructure development and capacity building, career development, linkages and resource and data sharing arrangements within and among Centers, and the interdisciplinary and multilevel nature of the research. Criteria for the evaluation component will be developed by NCI Program Staff in partnership with the Alliance Coordinating and Governance Committee (CGC) and other advisory committees of the program (as described in Section VI.2)

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Specialized Center Cooperative Agreement (U54) award mechanism. The Project Directors/Principal Investigators (PDs/PIs) will be solely responsible for planning, directing, and executing the proposed project.

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

In the cooperative agreement mechanism, the multiple Project Director(s)/Principal Investigator(s) (PD/PI) retain the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PDs/PIs, as described under the Section VI. 2. Administrative  and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award.”  Awards made under this program will continue as Cooperative Agreements throughout the term of the award.

2. Funds Available

Future year amounts will depend on annual appropriations.

Applicants may request a project period of up to five years and a budget in total cost of up to $3.2 million per year

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to submit applications in response to this FOA, but may participate on a subcontractual basis on applications submitted by eligible domestic applicant institutions.

1.B. Eligible Individuals

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

NOTE: PDs/PIs submitting a U01 application in response to the CNPP RFA-CA-09-013 or R25 application in response to CNTC RFA-CA-09-014 are NOT eligible to apply for the U54 CNNE award under this FOA as PDs/PIs. However, these individuals can serve as Project leaders, Core directors, or other key personnel investigators within a U54 CCNE application.

Given the need for integration of multidisciplinary efforts in CCNEs, applicants are expected to designate one senior investigator (PD/PI) to lead clinical translational oncology and another senior investigator (PD/PI) to lead the applied nanotechnology.  Additional PDs/PIs may be designated as appropriate, e.g. as leaders of individual research projects and/or Core directors.

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

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or 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 PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other - Special Eligibility Criteria

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewal. Renewal applications are not permitted in response to this FOA.  Even applications from the previous CCNE awardees will be treated as new applications.

Number of Applications. Applicant institutions may submit more than one CNNE U54 application in response to this FOA, provided that: each application is: (a) scientifically distinct and (b) proposed by a separate team of investigators (i.e., with different PDs/PIs and other key personnel).

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements.  The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.  The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked

The exceptions from the PHS398 instructions and detailed information on the application structure and components are provided in Section IV.6. Other Submission Requirements. All applicants must follow the specific instructions in that section.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs  

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

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

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a section of the research plan, entitled “Multiple PD/PI Leadership Plan” (section 14), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: September 14, 2009
Application Receipt Date: October 14, 2009
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: September 2010

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

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

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

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

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

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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

CCNE U54 applicants must demonstrate in the application their ability to meet:

Modifications to PHS398 Instructions for Application Preparation

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to replace standard Items 2-5 of the PHS 398 Research Plan with the following new sections:

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

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

RESEARCH PLAN: The standard PHS398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents) is altered as follows:

Note: Within the stated overall page limit, numbers of pages “suggested” in the text below for individual sections are provided solely as a nonbinding guidance for applicants. Applicants are encouraged to use the minimum number of pages necessary to describe the research plan clearly and succinctly.

Other items of the PHS398 Research Plan remain unmodified.

Section N1. Overview of the Proposed CCNE and Its Area of Focus (up to 15 pages total suggested)

Present the overall vision for the proposed CCNE including the following segments:

Section N2. Research Team and Research Capabilities, Center Organization and Infrastructure (Administrative Core) (up to 25 pages total suggested).

In this section, describe the following aspects of the proposed CCNE:

Note: All CCNE awardees will be expected to apply proper process management methods for planning, monitoring, and managing the workload over the award period and will be expected to share specific details of these aspects with NCI Program Staff members upon request. Therefore, applicants are encouraged to name a qualified project manager as the director of the Administrative Core (who would be in charge of the daily operations of the proposed center). 

Section N3. Individual C enter Projects (limited to 15 pages per each Project).

Each application must include three to five component projects closely pertinent to the research objectives (outlined in Section I of the FOA) and in line with the specific area of focus chosen for the proposed CCNE (to be defined in Section N1). It is required that: (i) at least one of these projects is oriented mainly to basic research and new discoveries and (ii) at least one project is oriented to clinical translation and the ultimate goal of technology commercialization.

Translational project(s) should substantially involve a for-profit entity that is expected to be a component of each CCNE team. Reviewers will assess the level of commitment of a for-profit entity to proposed projects in terms of likelihood for successful translation of technologies under  development to the clinic.

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

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

                                        ii.    Specific Aims;

                                       iii.    Background and Significance;

                                       iv.    Preliminary Results; and

                                         v.    Research Design and Methods.

                                       vi.    Milestones;

In order to be responsive to this FOA, applicants must provide a set of discrete, quantitative milestones for each research project proposed (for details see a Note below).

Section N4. Shared Resources (Cores) to Support Research Projects (up to 5 pages/Core suggested)

Applicants may propose, as needed, appropriate shared technical resources, or Cores. These shared resources must not duplicate analogous NIH-funded resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested). No more than 3 Shared Resources Cores may be proposed to support Research Projects (in addition to the required Administrative Core).

For all proposed CCNEs, it is recommended that, one Core is dedicated to bioinformatics and data sharing.

For each proposed Research Support Shared Resource Core include:

Section N5. Education/Training and Outreach Activities (up to 5 pages suggested)

In this section, describe the following:

Note: a minimum of $60K in direct costs must be allocated to these activities in the budgetary request.

Section N6. Developmental Activities (Plans for Pilot Projects, Alliance Challenge Projects, and Other Trans-Alliance Activities, up to 5 pages suggested)

Within the characteristics specified below, outline your vision on strategies and mechanisms for developing Pilot Projects and Alliance Challenge Projects and their evaluation/approval. Briefly describe how the ideas for these projects should be solicited and prioritized. Summarize key scientific and translational capabilities, which the applicant CCNE can provide to support such projects. Describe plans for outreach interactions to bring in expertise from outside of the individual CCNE to enhance specific efforts.

Do not list any specific projects (Pilot Projects or Challenge Projects) in this section.

Expected characteristics of Pilot Projects and Challenge Projects are as follows:

A)    Pilot Projects. Each CCNE applicant team must plan for developing Pilot Projects to be conducted within the Center. These projects are intended for the exploration of new ideas and emerging opportunities that may contribute to existing Center projects. A specific mechanism for the selection and approval of the Pilot Projects should be established by the leadership of the proposed CCNE in consultation with Project and Core Leaders. In general, the Pilot Projects should be short term (12 – 18 months) with a possibility of extension based on progress evaluation. Potentially, pilot projects may lead to larger research activities through seeking of separate funding in their later stages. All CCNE applicants must allocate a minimum of $70,000 in direct costs for Pilot projects.

B)    Alliance Challenge Projects. Each CCNE applicant team must plan for the participation in Alliance Challenge Projects involving collaborations with other Alliance awardees. Each CCNE awardee will take part in formulating overarching projects involving more than one center (or a center and a platform grant) through their participation in the Alliance Coordinating and Governance Committee (CGC) and communication with the Clinical Advisory Committee (CAC). All CCNE applicants must allocate a minimum of $110,000 in direct costs for these Alliance Challenge projects.

Other Trans-Alliance Activities. Describe your vision for any other trans-Alliance activities that could have a synergistic effect on its overall goals.

In this section, also describe how the proposed CCNEs may interface with the NCI Nanotechnology Characterization Laboratory (NCL) and caNanoLab (or similar public domain database).

OTHER REQUIREMENTS

Awardees must agree to the award administration information detailed in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award”.

Site Visits and Annual Alliance Meetings. Because of the complexity of the CCNEs, NIH/NCI program staff members will conduct annual administrative site visits. CCNE applicants must agree to participate in this process and should plan for annual visits (with appropriate budget, including travel for collaborators and other necessary costs).

Applicants must plan appropriate travel funds for the PD/PI and team leaders to participate in the annual Alliance meetings. They should also plan such funds for travel of technology transfer/intellectual property representatives (not more than two) of their institutions to these meetings.

Note on Quantitative Annual Milestones: As stated, each proposed research project must include a specific section labeled “Milestones” under Research Plan. Milestones should be scientifically justified and well-defined for each year of the project.

Whenever feasible, milestones should provide quantitative benchmarks for comprehensively assessing the annual progress of the projects. Milestones must not be simply a restatement of the specific aims. Rather, the milestones should offer a timeline and a “pathway” for the development of the proposed technology. These milestones will be used to judge the success of the proposed research on an individual-project basis and evaluate the criteria for the program. Applications that lack milestone information as determined by the NCI Program Staff will be returned to the applicant without review.

Examples of Quantitative Milestone:

a.     Detect one cancer cell in 106 normal blood cells.

b.    Enable the visualization of tumors consisting of <1000 cells.

c.     Reduce the effective dose of a therapeutic agent by one order of magnitude when conjugated with the targeting nanoparticle relative to the non-nanoparticle bound agent.

d.    Increase the therapeutic index of an agent >3-fold by nanoparticle-based therapeutic solution relative to the non-nanoparticle bound agent.

e.     Achieve >95% selectivity in targeting mixed cell populations in vitro.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

Data/resource sharing within institutions/organizations comprising a CCNE. In addition to the NIH wide requirements, all institutions/organizations participating in a given CCNE will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the CCNE award. An appropriate binding agreement, signed and executed by all entities participating in a given CCNE award (applicant institution and all institutions/organizations participating on a subcontractual basis) will need to be submitted prior to the initiation of the award.

Intellectual Property and Related Requirements. All CCNE applicants will be required to submit an intellectual property management plan and a plan to disseminate research results as a condition of award (just-in-time requirements). All awardees will be also required to sign the Alliance-wide agreement on the materials exchange among program participants. Details of these requirements are found in Section IV.6, “Other Submission Requirements.”

The intellectual property management plan needs to be included in the grant application. NCI Program Staff will consider the adequacy of the plans in determining whether to recommend an application for award. The approved plans would become a condition of the grant award and Progress Reports must contain information on activities for the sharing of research resources and intellectual property.

In the development of any research resource sharing and intellectual property management plans, applicants should confer with their institution’s office(s) responsible for handling technology transfer related matters and/or sponsored research. If applicants or their representatives require additional guidance in preparing such plans, they are encouraged to make further inquiries to the appropriate contacts listed above for such matters. Furthermore, applicants may wish to independently research and review examples of approaches considered by other institutions such as those described on the NCI Technology Transfer Branch web site (http://ttc.nci.nih.gov/intellectualproperty/). The foregoing guidance is provided by way of example to assist applicants in preparing the expected research resources sharing and intellectual property management plans in a manner that encourages partnerships with industry. While these approaches will likely suit most situations, these approaches are not exclusive and applicants should feel free to submit alternative versions for consideration.

The majority of transfers to not-for-profit entities should be implemented under terms no more restrictive than the Uniform Biological Material Transfer Agreement (UBMTA). In particular, recipients are expected to use the Simple Letter Agreement (SLA) provided at http://www.ott.nih.gov/pdfs/slaform.pdf, or another document with no more restrictive terms, to readily transfer unpatented tools developed with NIH funds to other recipients for use in NIH-funded projects. If the materials are patented or licensed to an exclusive provider, other arrangements may be used, but commercialization option rights, royalty reach-through rights, or product reach-through rights back to the provider are inappropriate. Similarly, when for-profit entities are seeking access to NCI-funded tools for internal use purposes, recipients should ensure that the tools are transferred with the fewest encumbrances possible. The Simple Letter Agreement (SLA) may be expanded for use in transferring tools to for-profit entities, or simple internal use license agreements with execution or annual use fees may be appropriate.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

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

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 CriteriaReviewers 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 Center address an important problem or a critical barrier to progress in the field?  If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center?  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 Center 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 Center proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

NIH considers the following in evaluating Center grant applications:

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

(A) Review Criteria for Overall CCNE Evaluation

1)     Overall Significance:  Does the proposed CCNE address an important cancer problem with the application of an innovative nanotechnology-based solution? What is the likelihood that the proposed CCNE will ultimately lead to the development of translational, clinically worthy solution(s) to prevention, diagnosis, or therapy of cancer? Will the proposed CCNE have a significant impact on the broader field of biomedical nanotechnology applications (beyond cancer)?

2)     Overall Approach:  How well does the proposed CCNE take advantage of multidisciplinary approaches to promote and advance both discovery and application of innovative nanotechnology solution(s) to important cancer problem(s)? Are the overall research goals, experimental design, methods, and capabilities sound and well developed? Are effective mechanisms in place to foster strong collaborative interactions and promote “cross-fertilization” among investigators (and participating institutions) representing both oncology/cancer biology and applied nanotechnology/engineering/physical sciences? Is the involvement of clinicians in the proposed preclinical studies sufficient to support the development of nanotechnology-based solution(s) to the point where rapid translation into clinical trials is achievable? Will these goals be advanced through a meaningful participation of a commercial entity?

3)     Leadership and Research Teams:  Is there adequate evidence for the managerial and collaborative capabilities of the proposed CCNE leadership? How appropriate is the leadership structure of the proposed CCNE in terms of (a) the overall goals of CCNEs; (b); the coordination of efforts of multiple institutions participating in a given CCNE; and (c) the participation in and coordination of trans-Alliance activities? Are the backgrounds, expertise, and commitments of the PDs/PIs and other key personnel sufficient for the proposed scope of activities and in line with the overall goals for CCNEs? For applications involving multiple PDs/PIs, are their designated roles and responsibilities well defined, adequate, and appropriate for achieving the goals of the proposed CCNE?

4)     Organizational Framework and Integration: How well do all the proposed efforts take advantage of the infrastructure of the proposed CCNE and existing resources of the participating institutions? Will the proposed Administrative Core effectively coordinate the efforts of the participating institutions and outside interactions at the trans-Alliance level? Is there evidence of sufficient institutional support for the proposed CCNE across the participating institutions? Will the interactions across the individual Research Projects and Shared Resource Cores result in significant transdisciplinary synergism and an integrated “value added” outcome? Is there evidence of ongoing productive interactions among participating investigators/institutions? Will the Shared Resource Cores enhance the capabilities of individual research projects? Are the plans for pilot projects and the participation in the Alliance Challenge projects adequately described and appropriate for the goals of the CCNE? How appropriate and balanced are the proposed training and education activities in the context of the specific research goals proposed?

(B) Review Criteria for Individual Research Projects

1)     Significance: Does this study address an important problem with the use of nanotechnology? If the aims and milestones of the project are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods important to the field?

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

3)     Innovation: Does nanotechnology provide best innovative method to solve the problem stated in the study? Does the proposed project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

4)     Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the project proposed appropriate to the experience and expertise of the project leader and other researchers and team members?

5)     Environment: Does the scientific environment in which the work will be done contribute to the probability of success?  Do the proposed experiments benefit from unique features of the scientific environment or employ useful collaborative arrangements?

6)     Milestones: Are the milestones adequately comprehensive, quantitative and realistic? Will these milestones allow for sufficiently accurate and informative evaluation of the progress of the project proposed?

(C) Review Criteria for Shared Resource Research-Support Cores

Is the proposed Shared Resource Core well matched to the needs of the overall program?  Does it provide essential facilities/services to the research projects? Are there feasible and clear plans for prioritizing the use of shared resource cores, their availability to the proposed research projects, and their efficient utilization? Are the qualifications, experience, and commitment of the Shared Resource Core Director(s) and other key personnel adequate and appropriate for providing the proposed facilities or services? Will the use of core services be cost effective to the Program? 

(D) Review Criteria for Education/Training and Outreach Program

Are there sufficient and appropriate resources dedicated to the proposed training program (in terms of technical and scientific expertise, mentoring experience, and the availability of faculty and other staff members)? Is the available training infrastructure, such as laboratories, clinics, etc. (as documented in the application), sufficient for the proposed career development and training activities? Are the plans for the evaluation of the efficiency of the proposed training program adequate?

(E) Review Criteria for Developmental Activities

Are the plans for Pilot Projects realistic and sufficient for flexible exploration of new ideas within the proposed CCNE? How likely are the applicants to contribute to the development and conduct of significant Alliance Challenge projects? What is the potential of the proposed CCNE for a meaningful synergy with other Alliance components?  Would the proposed CCNE benefit from collaborative interactions with the Alliance? Will the described plans allow sufficient flexibility in collaboration with the Alliance?  Will the investigators bring valuable areas of expertise to the Alliance that will maximize flexibility for the program?

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

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

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

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

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

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

Additional Review Considerations.  As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact 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 Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s) and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in Item 12 on the Application Face Page).  If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

These Terms and Conditions of Award apply to all individual CCNE U54 awards.  All the awardee institution(s), principal investigators (PDs/PIs) and other key personnel must agree to collaborate on the goals of the CCNE and the entire NCI Alliance for Nanotechnology in Cancer.

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

The Principal Investigator(s) will have the primary responsibility for:

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

Each CCNE award and the entire Alliance program will be periodically evaluated by the NIH. Awardees will be expected to participate in such evaluation.

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

2. A.2. NIH Responsibilities

NCI Program Staff, acting as Project Scientists, will have substantial programmatic involvementthat is above and beyond the normal stewardship role in awards, as described below:

NIH is expected to form a Cancer Nanotechnology Working Group (NIH-CNWG), which will be available to the Alliance as a resource. The NIH-CNWG will include representatives from NCI organizational units (e.g., DTP, CIP, Cancer Prevention Division, NCICB, and CCR), as well as other NIH institutes and initiatives (e.g., NIBIB, NHLBI, Nanomedicine Roadmap), and Federal agencies (e.g., FDA, and NIST). The NCI Project Scientists will coordinate interactions between the NIH-CNWG and the Alliance.

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

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice.  A Program Official may also have substantial programmatic involvement (as a Project Scientist).  In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications, or will seek an NCI waiver.

2.A.3. Collaborative Responsibilities

The Alliance Coordination and Governance Committee (CGC) will serve as the main governing board for the NCI Alliance for Nanotechnology in Cancer program. The committee will consist of the following voting members:

Each voting member representing the Alliance awardees will have one vote. Each voting NCI Project Scientist will have one vote. Responsibilities of the CGC will include the following aspects:

In addition, the designated NCI Program Director (who can also act as a Project Scientist) and the representative of the NCI Nanotechnology Characterization Laboratory (NCL) will participate in the activities of the CGC as non-voting members. Additional non-voting members to serve in an advisory capacity may be added to the CGC as needed by a decision of the existing voting committee members.  These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other federal agencies (e.g., Food and Drug Administration [FDA], National Institutes of Standards and Technology [NIST], and Department of Defense [DoD]).

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

The CGC will have primary responsibility for the overall organizational oversight of the NCI Alliance for Nanotechnology in Cancer program and for review of its research goals. 

The Alliance Coordinating and Governance Committee (CGC) will:

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

The CGC will additionally establish two advisory panels (sub-committees) to serve the CGC and the program awardees:

CAC will facilitate further involvement of clinicians in cancer nanotechnology and will provide guidance in terms of assessing maturity of the projects and their potential for clinical utility solutions. CAC will consist of 5-6 members, with three (3) being clinical investigators with the funding from the Alliance and the other three (3) – clinicians established in the development of new technologies for cancer solutions, but not funded from the program. CAC will work closely with IAC;

IAC will consist of representatives from for-profit organizations (5-6 members) involved in the commercialization of nanotechnology-based oncology solutions. IAC will provide advice on translational strategies and forming appropriate partnerships leading to successful commercialization. The recommendations and approval of CAC and IAC membership will be performed by CGC.

Additionally, consulting/supporting role will be played by the NIH-CNWG. Members of the NIH-CNWG may be invited as appropriate to  CGC meetings.

Representatives of CAC, IAC, and NIH-CNWG will also be invited to participate in the Alliance annual PD/PI meeting; in addition they will meet by telephone conference two (2) times a year.

2.A.4. Dispute Resolution

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. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's rights in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

In addition to the standard NIH Form 2590 progress report (submitted once a year), a more detailed Center progress report (Specialized Interim Reports) will be required twice a year.

These semi-annual Specialized Interim Reports will have to follow the specific guidelines developed by NCI Program Staff. The Specialized Interim Reports will be submitted directly to the NCI Program Director (with a copy to the designated Grants Administration official). The required content of the Specialized Interim Reports may be changed according to programmatic needs based on the discussion among the Alliance members, CGC, and the NCI.

Should problems arise in the conduct of the study, the NCI may require that the Center awardee submit quarterly reports on progress and fiscal matters.

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.  Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues.

1. Scientific/Research Contacts:

Dr. Piotr Grodzinski
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 10A28, MSC 2580
Bethesda, MD 20892
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: grodzinp@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Emily Linde
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD  20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Phone: (301) 496-8784
Fax: (301) 496-8601
E-mail:  lindee@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with the 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.

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

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

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

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

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

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

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

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


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