and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)
Components of Participating Organizations
National Cancer Institute http://www.cancer.gov/
Title: Cancer Nanotechnology Platform Partnerships (U01)
Announcement Type
This is a reissue of RFA-CA-05-026.
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-CA-09-013
Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 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
PRE-APPLICATION MEETING
The NCI anticipates holding a pre-application meeting on Thursday, July 23, 2009 at 10 am 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 Cancer Nanotechnology Platform Partnerships (U01) and its interaction with the NCI Alliance for Nanotechnology in Cancer initiative such as the Centers of Cancer Nanotechnology Excellence (CCNEs). In addition, the pre-application meeting will discuss the application peer review process, and 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 enable the development of transformative nanotechnology solutions to cancer-relevant problems by supporting multi-disciplinary research under Cancer Nanotechnology Platform Partnerships (CNPPs) awards. CNPPs will become an integral component of the NCI Alliance for Nanotechnology in Cancer program (first established in 2004; http://nano.cancer.gov). In addition to CNPPs, the Alliance will consist of the Centers of Cancer Nanotechnology Excellence (CCNEs, as the core of the program infrastructure) and two training programs. The CNPP initiative (covered by this FOA) is designed to promote and support individual, circumscribed multi-disciplinary research projects that will address major barriers and/or fundamental questions in cancer using innovative nanotechnology solutions. The proposed projects may be pertinent to diverse aspects of broadly defined basic and/or pre-clinical cancer research but all are expected to have exceptionally high potential for transformative discoveries. It is expected that this initiative will generate potentially new paradigm shifting research outcomes, which may ultimately lead to novel preventive, diagnostic, and therapeutic approaches to modulate and overcome cancer processes. The CNPPs created under this FOA will be expected to take advantage of the Alliance infrastructure and to collaborate with the CCNEs.
To build multidisciplinary teams needed to support the goals of this FOA, applicants are encouraged to take advantage of the multiple Program Directors/Principal Investigators (PDs/PIs) option with one PD/PI representing oncology or biology and another PD/PI representing fields of chemistry, physics, or engineering.
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.
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, founded in 2004, 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 cancer nanotechnology field has excellent potential for 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 the therapy as well as monitoring of therapeutic efficacy. It is expected that 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:
The Alliance will also be directly supported by the following NCI efforts:
Specific Research Objectives and Requirements for CNPPs
All applications submitted in response to this FOA must conform to the overall research objectives and requirements of this FOA. Thus, all the proposed CNPPs must have the following attributes:
Possible Research Directions
Several examples of possible topics of such research (see below) have emerged from the strategic cancer nanotechnology workshops carried out by the NCI in 2008 (http://nano.cancer.gov/meetings_events/Strategic_Workshops_on_Cancer_Nanotechnology_-_CancerRes_final_.pdf). Additional topics are also encouraged, providing they fit into the overall goals of CNPPs and conform to other requirements. Moreover, applicants should bear in mind that various topics are not necessarily mutually exclusive and may be combined in a single project, if appropriate.
Potential research directions for CNPP projects include (but are not limited to) the following examples:
Tumor Types. Regardless of a specific topical area of the proposed projects, all CNPP applicants are encouraged (but not required) to concentrate their efforts on tumor types, where the disease is characterized by low survival rates: brain, lung, ovary, and pancreas.
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.
Trans-Alliance Activities. Each proposed CNPP will be expected to interact with other components of the Alliance, in particular with one (or more) CCNEs. Specifically, CNPPs must plan for the participation in the development and conduct of the collaborative pilot projects (termed Alliance Challenge projects) and for other trans-Alliance activities.
CNPP applicants are encouraged to consider establishing partnerships with other groups and divisions within NCI that may benefit the CNPP. 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 will provide viable assistance in this process.
Beyond the Alliance and other NCI resources, CNPP 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 CNPPs. 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 FOA.
Governance of the NCI Alliance for Nanotechnology in Cancer
The Alliance, including CNPPs, will be governed by the Alliance Coordinating and Governance Committee (CGC). The CGC will oversee and coordinate the activities of all centers (CCNEs), platforms (CNPPs), and training centers (CNTCs). Details on the composition and functions of the CGC are provided in Section VI.2.A.3, Terms and Conditions of Cooperative Agreement (under Collaborative Responsibilities ).
Evaluation of the Program
As the efficiency of the funded research is an increasing priority for NCI, CNPPs 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, effectiveness of collaborative research development model, and others.
The purpose of the evaluation process is to monitor and assess the performance of the CNPPs in achieving the goals of this FOA. This process includes evaluating the quality and innovation of the research conducted at the CNPPs, as well as assessing other critical indicators, including collaborations and resource and data sharing across the Alliance. 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.3)
1. Mechanism of Support
This funding opportunity will use the NIH U01 Research Project Cooperative Agreement award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. .
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" (Form Page 4) and the " Entire Proposed Project Period" (Form Page 5) is to be submitted with the application.
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
F&A costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 designated on a U54 application in response to the CCNE RFA-CA-09-012 are NOT eligible to apply as PDs/PIs for the U01 CNPP award under this FOA as PDs/PIs. However, these individuals can serve as other key personnel investigators on the U01 applications.
Given the need for integration of multidisciplinary efforts in CNPPs, applicants are encouraged to take advantage of the multiple PDs/PIs option with one PD/PI representing oncology or biology and another PD/PI representing the fields of chemistry, physics, or engineering.
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).
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.
Number of Applications. Applicant institutions may submit more than one CNPP U01 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) 710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the current PHS 398 research grant application instructions and forms 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.
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
Applications are encouraged to use the multiple PDs/PIs mechanism. Use the Face Page-Continued page to provide items 3a 3h for all PDs/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PDs/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PDs/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PDs/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
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 IC 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
or
Dr. Larry A. Nagahara
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: nagaharl@mail.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
3.C. Application Processing
Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements
CNPP (U01) 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).
RESEARCH PLAN: The standard PHS398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as Sections A-D ) is altered as follows:
Note: Numbers of pages suggested below for individual sections are provided solely as a nonbinding guidance for applicants. Applicants are encouraged to use the minimum number of pages necessary to describe the research plan clearly and succinctly.
Other items of the PHS398 Research Plan remain unmodified.
Section N1. Research Team, Leadership and Administrative Activities (up to 5 pages total suggested).
Applicants are encouraged to designate multiple Program Directors/Principal Investigators (PDs/PIs), where one PD/PI represents oncology or biology and another PD/PI represents the fields of chemistry, physics, or engineering.
In this section, describe the following aspects:
Section N2. Research Project (20 pages suggested).
The proposed research project must address a major barrier and/or fundamental question in cancer using nanotechnology. Applicants must clearly describe why the proposed research will have a potentially high impact on the field and how it will overcome currently existing barriers and knowledge gaps. The applicants must also provide a set of discrete, preferably quantitative milestones for the project.
Nanotechnology-based tools, techniques, devices and/or materials must meet the criteria for nanotechnology as defined in this FOA.
Project description must contain the following elements:
i. Project Overview;
ii. Specific Aims;
iii. Milestones (see Note in Section IV.6. Other Submission Requirements);
iv. Background and Significance;
v. Preliminary Results and
vi. Research Design and Methods.
Section N3. Trans-Alliance Activities (up to 3 total pages suggested)
Alliance Challenge Projects. Each CNPP applicant must plan for the participation in the collaborative Alliance Challenge Projects. It is envisioned that such projects will address shared needs of the Alliance (to be prioritized by the Alliance CGC) and will take advantage of the synergistic capabilities of the Alliance investigators. It is also envisioned that, typically, CNPP awardees will collaborate with CCNEs in the design and conduct of specific Alliance Challenge Projects. In the budget requests, all CNPP applicants must allocate a specific item for these Alliance Challenge Projects (a minimum of $25,000/year in direct cost).
In Section N3, applicants should describe their vision strategies and mechanisms for developing such projects and their evaluation/approval at the level of the Alliance CGC. Briefly describe how the ideas for the Alliance Challenge Projects (as described in Section I.) should be solicited and prioritized. Do not list any specific projects but summarize key scientific and translational capabilities which the applicant CNPP can provide to support such projects. Describe plans for outreach interactions to bring in expertise from outside of the individual CNPP to enhance specific efforts.
Other trans-Alliance Activities. Describe your vision for any other trans-Alliance activities that could have a synergistic effect on its overall goals.
Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI2.A Award Administration Information.
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 comprehensive assessment of 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 Milestones:
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 an 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.
Alliance Meetings:
CNPP investigators will be expected to attend the annual PD/PI Meeting and participate in CGC activities (if selected) to discuss their research progress. Funds to support travel of the key investigators to attend the annual PD/PI meetings should be included in the application budget.
Appendix Materials
All paper PHS 398 applications must provide appendix material on CD only, and include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in 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 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 CNPP. In addition to the NIH wide requirements, all institutions/organizations participating in a given CNPP will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the CNPP award. An appropriate binding agreement, signed and executed by all entities participating in a given CNPP award (applicant institution and all institutions/organizations participating on a subcontractual basis) will be required prior to the initiation of the award.
Intellectual Property and Related Requirements. All CNPP applicants will be required to submit an intellectual property management plan and a plan to disseminate research results as a condition of award. 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 institutions' 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. Further, 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. Whereas 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.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, specific to this FOA: What is the potential of the proposed project for a paradigm shifting (non-incremental) advancement in cancer biology and/or disease detection, treatment, and prevention with the use of nanotechnology?Is the proposed project focused on the tumor type with poor survival rate? Will the advances have a significant impact on the broader field of biomedical nanotechnology applications (beyond cancer)?
Investigator(s). Are the PDs/PIs, collaborators, and other researchers well suited to the project? 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 project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, specific to this FOA: Does the proposed research team provide appropriately balanced leadership and expertise in both oncology/cancer biology and applied nanotechnology/engineering/physical sciences? Does the research team have a track record of prior successful collaborative research? If collaborating institutions involve industry or small business entities, how will this inclusion enhance the applicants research and their plans for technology translation/dissemination? For applications involving multiple PDs/PIs, are their designated roles and responsibilities well defined, adequate, and appropriate for achieving the goals of the proposed CNPP? How appropriate is the leadership structure in terms of coordination of efforts of multiple institutions participating in a given CNPP?
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?
In addition, specific to this FOA: Does nanotechnology provide best innovative method to solve the problem stated in the study?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
In addition, specific to this FOA: How well does the proposed CNPP take advantage of multi-disciplinary approaches? Are the interim milestones of project progress milestones adequately comprehensive, quantitative wherever feasible, and realistic? Will these milestones allow for sufficiently accurate and informative evaluation of the progress of the project proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
Trans-Alliance Interactions: What is the potential of the proposed research team for a meaningful synergy with other Alliance components? Would the project proposed benefit from collaborative interactions with the Alliance? How likely are the applicants to contribute to the development and conduct of significant Alliance Challenge projects? Will the application allow flexibility in collaboration with the Alliance? Will the investigators bring valuable areas of expertise to the Alliance that will maximize flexibility for the program? Does the application describe prior successful collaborative research?
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).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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 Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
These Terms and Conditions of Award apply to all individual CNPP U01 awards. All the awardee institution(s), principal investigators (PDs/PIs) and other key personnel must agree to collaborate on the goals of the CNPP 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 CNPP will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the CNPP award.
Each CNPP 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 involvement that 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 NCI waiver according to the NCI procedures for management of conflict of interest.
Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as a Project Scientist). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications, or will seek NCI waiver.
2.A.3. Collaborative Responsibilities
The 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 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 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 Alliance and for reviewing the research goals among the participants.
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 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 funded by clinical investigators 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, NIH-CNWG will serve in a consulting/supporting role. Members of the NIH-CNWG may be invited as appropriate to the CGC meetings.
Representatives of CAC, IAC, and NIH-CNWG will also be invited to participate in the Alliance annual PI meeting; in addition they will meet by telephone conference 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.
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 this standard NIH Form 2590 progress report (submitted once a year), a more detailed project 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 CGC and 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 CNPP awardee submit quarterly reports on progress and fiscal matters.
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.
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 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: grodzinp@mail.nih.gov
or
Dr. Larry A. Nagahara
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: nagaharl@mail.nih.gov
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 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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