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: Cancer Nanotechnology Training Centers (CNTCs)(R25)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-CA-09-014

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.399

Key Dates
Release/Posted Date: October 9, 2009
Opening Date: November 17, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 17, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): December 17, 2009
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: December 18, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Education Objectives

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

Section III. Eligibility Information
1. Eligible Applicants

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency 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 Education Objectives

Purpose

The overall purpose of this funding opportunity announcement (FOA) is to promote the development of a multi-disciplinary nanotechnology workforce capable of pursuing cancer research through the formation of Cancer Nanotechnology Training Centers (CNTCs) as institutional research education/training programs. The CNTCs will become an integral component of the NCI Alliance for Nanotechnology in Cancer program (http://nano.cancer.gov). In addition to the CNTCs, the Alliance will consist of the Centers for Cancer Nanotechnology Excellence (CCNEs, as the core of the program infrastructure), platform projects (CNPPs), and a K99/R00 career transition program. The CNTCs to be created under this FOA will be expected to take advantage of the Alliance infrastructure and to collaborate with the CCNEs and CNPPs.

The main goal for CNTCs is to educate and train researchers from diverse fields in the use of nanotechnology-based approaches to advance understanding of cancer biology and/or create new methods/tools for the prevention, diagnosis and/or treatment of cancer.

The relevant research education/training program should include a combination of:

To advance the goal of creating a multi-disciplinary workforce, the scope of the proposed research education/training program should encompass pertinent aspects of the medical and biological sciences as well as chemistry, physics and engineering. The proposed CNTCs should target graduate student and post-doctoral researchers of broad background, spanning all of the mentioned fields.

The main thrust of CNTC research education program should be on the mentored laboratory training program. Participants (graduate student and post-doctoral researchers) should be recruited from diverse academic and clinical disciplines. Individual research experiences under this program can be for a period of up to two years. and may be either full time or part time.

With the goal to train interdisciplinary workforce, the thrust of laboratory-based experiences should be on cross-training in disciplines different that the main area of expertise of the participant.

Self-standing short-term courses/workshops may also be proposed in the CNTC program. These courses should also target participants from diverse academic and clinical disciplines.

Candidates for training may be recruited from the home institution of the proposed CNTC or from outside institutions. However, the CNTCs will be expected to offer facilitated access to their research education/training opportunities to participants from institutions affiliated with the Nanotechnology Alliance.

To build the 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 definition of nanotechnology as specified by the National Nanotechnology Initiative (NNI); http://nano.gov/html/facts/whatIsNano.html as a guideline. Specifically, to be responsive to this FOA, the proposed research education/training programs must focus on materials/technologies/devices that 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 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: Research educational topics focused solely on naturally-occurring materials (e.g., carbohydrates, proteins, viruses) that are not specifically engineered or modified for a biomedical application are not responsive to 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 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 (representing 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 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 (to be funded through RFA-CA-09-012) are expected to be the main venue for discovery and tool development towards prospective applications of nanotechnology in clinical oncology. CCNE teams will be required to focus on integrated technology solutions which have practical clinical applications, to pursue aggressive development of these solutions to the pre-clinical stage, and to provide a path to clinical translation. It is also expected that students and post-doctoral fellows working within CCNE structures will be immersed in an educational multi-disciplinary environment contributing to shaping their knowledge and future careers. Each funded CCNE will have a training/educational module.
  2. Cancer Nanotechnology Platform Partnerships (CNPPs). Smaller circumscribed nanotechnology projects will be funded under “platform” awards (U01 funding mechanism, funded through RFA-CA-09-013).
  3. Cancer Nanotechnology Training Centers (CNTCs). Multi-disciplinary research education training centers aiming to establish a cadre of researchers who are skilled in applying the tools of nanotechnology to critical problems in cancer research and clinical oncology will be funded under this FOA.
  4. K99/R00 - pathway to independence awards will be also available to facilitate funding for junior faculty in cancer nanotechnology (under RFA-CA-09-015).

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 the 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). caNaoLab is designed to enable sharing of nanotechnology data and to expedite and validate the use of nanoparticles in biomedicine.

Specific Research Objectives and Requirements for CNTCs

Cancer Nanotechnology Training Centers to be proposed in response to this FOA are designed to create new opportunities for multi-disciplinary research education training in cancer nanotechnology.

Center program should encompass the following activities:

  1. Laboratory based mentored training through participation in multidisciplinary research projects dedicated to nanotechnology innovation in cancer biology and oncology (up to 2 years per individual participant);
  2. Workshops, seminars, and short courses (a few days to two weeks) in specialized areas relevant to cancer nanotechnology. This component may include laboratory training modules to introduce participants to specific techniques, methodologies and approaches from a variety of disciplines that are relevant to cancer nanotechnology.
  3. An outreach program consisting of educational materials for the general public and cancer patient community, e.g. a Center website, brochures, public seminars and lectures.

Although Center research projects must have sound scientific and technical merit, the primary emphasis should be well designed hands-on laboratory research training for participants. It is expected that projects will be collaborative in nature and will require a diverse set of laboratory skills encompassing techniques from both the physical and medical/biological sciences. The skills and knowledge acquired in the course of these projects should be easily transferable to other areas of cancer nanotechnology research.

Targeted Participants

CNTC mentored research training projects are intended for graduate students and post-doctoral researchers planning to pursue careers in cancer nanotechnology research. Individual participants in mentored research training projects may be supported by the CNTC for up to 2 years. After this time, arrangements for alternate funding should be made to support continued work on the project, if desired. Participation in Center projects may comprise part of a graduate student’s thesis research. Part-time participation in Center projects is allowable for both graduate students and post-doctoral researchers. Post-doctoral researchers should be encouraged to pursue research areas outside of their graduate field of expertise.

Center seminars, workshops, courses, and other forms of short-term research education/training may be open to interested students and researchers at large (not restricted to those participating in Center research education/training projects).

Other activities should include elements facilitating career development for participants, including experience with grant writing and student supervision, when feasible. Examples include programs for participants to prepare mock NIH grant applications subject to review by Center faculty and opportunities for post-doctoral participants to oversee undergraduate student research projects.

CNTC applicants should define the expected numbers of full time and part time participants, the proportion of graduate students to postdoctoral fellows. Specific candidates should NOT be listed. However, sources of candidates and the recruitment and selection procedures should be outlined.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

Multidisciplinary Scientific Scope of CNTC

The topics of CNTC educational research projects, courses, and other activities should be chosen to construct a research education program that is multi-disciplinary and spans multiple facets of the field of cancer nanotechnology. The choice of research projects should also maximize instructive value and foster the development of laboratory training modules for techniques and methodologies important in cancer nanotechnology. The modules developed should be adaptable to other research programs.

It is envisioned that each CNTC’s mentored research program will span a range of complementary areas of cancer nanotechnology with individual research projects designed to interact with one another.

In general, research education activities of CNTCs (including mentored research projects and smaller laboratory training modules) are expected to be relevant to research priority areas that have emerged from the strategic cancer nanotechnology workshops carried out by NCI in 2008 (http://nano.cancer.gov/meetings_events/Strategic_Workshops_on_Cancer_Nanotechnology_-_CancerRes_final_.pdf). Additional topical areas are also encouraged, providing they fit into the overall goals for the CNTCs and conform to other requirements. Examples of appropriate areas include, but are not limited to:

Applicants are strongly encouraged to structure the leadership of the proposed CNTC around two senior researchers of synergistic scientific backgrounds, with one representing the biological sciences and/or clinical oncology and another applied nanotechnology. These senior researchers should work jointly to recruit appropriate faculty, identify laboratories and investigators who could serve as mentors for Center participants, and oversee the development of appropriate courses/workshop curriculum and the nanotechnology educational research program. The breadth of the multidisciplinary expertise of CNTC leaders, faculty members, and potential mentors as well as their experience in training and mentoring successful laboratory researchers and/or clinical investigators will be evaluated by reviewers and will have an important impact on the overall merit of the CNTC applications.

Trans-Alliance Activities. CNTC applicants are encouraged to plan for the interactions of the proposed Center with the other components of the Alliance, specifically the CCNEs and CNPPs (to be supported by RFA-CA-09-012 and RFA-CA-09-013, respectively). These interactions may include sharing educational materials developed at the CNTC with other Alliance members and arranging for the exchange of participants/personnel with other Alliance-affiliated institutions. CNTCs senior members will also be expected to participate in certain trans-Alliance events, including Alliance PI meetings and, possibly, in the activities of the Alliance Coordinating and Governance Committee (see details below).

Laboratories affiliated with CNTC applicants may benefit from establishing partnerships with other groups and resource programs within NCI, such as Rapid Access to Intervention Development (RAID, http://www.dtp.nci.nih.gov/docs/raid/raid_index.html), the Cancer Therapy Evaluation Program (CTEP, http://ctep.cancer.gov/), and the Nanotechnology Characterization Laboratory (http://ncl.cancer.gov/).

Applicants may also be interested in the NSF Nanoscale Science and Engineering (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://foundry.lbl.gov/nsrc/nsrc_prog.html) which offer opportunities for partnerships commensurate with those expected from the CNTCs. The NSE 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 CNTCs, will be governed by the Alliance Coordinating and Governance Committee (CGC). The CGC will oversee and coordinate the activities of all research centers (CCNEs), platforms (CNPPs), and training centers (CNTCs). Representatives of CNTC awardees will be members of the CGC. Applicants responding to this FOA are encouraged to familiarize themselves with the details on the composition and role of the CGC that are provided in RFA-CA-09-012 and RFA-CA-09-013.

CNTC versus other ongoing research training programs

The proposed research education and training programs for CNTCs may complement other ongoing research training and education programs at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support and provide added value. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

Evaluation of the Alliance Program

The entire Alliance program, including CNTC component, will be subject to external evaluation required for all NCI-sponsored Requests for Applications (RFAs). In this evaluation process, the Alliance CNTC awardees will be encouraged to cooperate with the NCI staff and program evaluators. This cooperation may involve being prepared for a site visit or an interview and furnishing information that might be needed for program evaluation.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Education Grant (R25) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed research education program.

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

Research education grant support is for new projects only; renewal (formerly “competing continuation”) applications will not be accepted.

2. Funds Available

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

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

The size of award may vary with the scope of the research education program proposed. Applicants may request a project period of up to five years and a maximal budget in direct cost of up to $400,000 per year.

It is anticipated, however, that the number of institutions that would have a cadre of investigators/mentors with appropriate expertise and resources sufficient to propose a full-fledged CNTCs (with the maximal allowable budget) may be limited. Therefore, applications for programs smaller in scope (with commensurably lower budget requests) are also encouraged.

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

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement is $2.5 million dollars in total costs for FY 2010 to fund three to five awards. Future year amounts will depend on annual appropriations.

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 apply in response to this FOA.

In many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

1.B. Eligible Individuals

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

The PD/PI should be an established investigator in the area of nanotechnology and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program.

Note: PDs/PIs submitting a U54 application in response to the CCNE RFA-CA-09-012 are NOT eligible to apply for the R25 CNTC award under this FOA as PDs/PIs (but may serve as faculty or mentors).

More than one PD/PI (i.e., 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 and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (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 grant 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. When considering the multiple PD/PI option, 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 research education program, 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

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. The application must have a strong research program in the area(s) cancer-relevant nanotechnology proposed for research education activities. The institutional commitment to the proposed research education program needs to be documented in an appropriate letter of support (to be included in the application).

Participants: CNTC mentored research training projects are intended for graduate students and post-doctoral researchers planning to pursue careers in cancer nanotechnology research.

Center seminars, workshops, courses, and other forms of short-term research education/training may be open to interested students and researchers at large (not restricted to those participating in Center research education/training projects), who wish to learn the latest developments in the field of cancer nanotechnology or wish to be cross-trained in relevant sub-fields.

Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Evaluation Plan: Applications must contain an evaluation plan in order to determine the effectiveness of research education/training program. Applications submitted without Evaluation Plan section may be delayed in the review process or not reviewed.

Dissemination Plan: Applications must contain a dissemination plan in order to determine their effectiveness. For the applications submitted in response to this FOA, the description of the proposed Outreach Program will also serve as the Dissemination Plan.

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

Renewals. Renewal applications are not permitted in response to this FOA.

Number of Applications. Applicant institutions may submit only one application under this FOA.

Section IV. Application and Submission Information


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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

1. Request Application Information

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

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

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

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

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

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

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

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the 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” [Section 14 of the Research Plan Component in the SF424 (R&R)], 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 program 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.

Research Education Program

While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements.

A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc. (This plan should be included in the description of the Outreach Program).

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented, and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution, nor can they be used to circumvent or supplement funds provided to individuals supported by Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget.

Applicants may request salary and fringe benefits for PD/PIs and other individuals substantially participating in the design and implementation of the research education program at a level appropriate for the person months effort devoted to the program. Base salaries indicated for personnel costs calculations may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then no budgetary request for such activities is allowed, even if a given individual is involved in the program (with a specified person-months effort level).

Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be requested in the proposed budget, if needed, but only when specifically identified and adequately justified.

It is expected that in aggregate no more than 20% of the total direct costs for each CNTC will be allocated to personnel costs (other than participants salaries).

Other Program-Related Expenses: These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.

Support for Mentored Research Projects. Up to $20,000 for a pre-doctoral participant per year and up to $30,000 for a post-doctoral participant per year in direct costs (prorated for the actual months-effort) can be provided for the following types of expenses: (a) research expenses, such as supplies; (b) tuition and fees related to career development; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Specific categories of expenses are expected to depend on individual candidates, their educational background, and specific career development goals and activities taken. CNTC applicants should estimate such costs cumulatively for the intended number and profiles (career levels) of the targeted participants.

Support for Short Courses/Workshop, Seminars, and Other Activities. Modest costs associated with the organization of courses, workshops, etc., that will not be offset by registration fees may be budgeted. It is recommended that in planning such activities, applicants rely on space, laboratories, and other resources of their institutions to limit the expenses.

A small proportion of the budget can be used for advertising and recruitment in order to attract the best possible candidates to the Program.

NOTE 1: Applicants should request travel funds for the CNTC PDs/PIs or designated senior investigators (up to two persons) to attend the annual Alliance meeting.

NOTE 2: Consultant costs, equipment, and supplies for key personnel are not allowed.

NOTE 3: Even though equipment costs are generally not allowable under this FOA in exceptional situations modest and very well justified equipment requests may be considered on case by case basis.

Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

CNTC funds may be used for salaries (including fringe benefits) for individual participants in the Center program either part time or full time. However, an individual participant may be supported by the CNTC for no longer than 24 calendar months (regardless of actual person-months effort level).

Salary amounts for all participants must conform to the established, consistently applied salary and wage policies of the applicant institution and must be appropriately pro-rated to reflect the level of effort (person-months) devoted to the program. Participants should receive compensation that is comparable to NRSA stipends for similar levels of training and in accordance to NIH policy (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html). For current NRSA stipend levels for graduate (pre-doctoral) students and post-doctoral fellows see NOT-OD-09-075.

NOTE: CNTC applicants do not have to list names of individual candidates for participants but should define the intended sources of candidates, outline the recruitment and selection procedures, and indicate the anticipated number of participants in a full time and part-time status.

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged.

A letter of institutional commitment may be attached at line item 16 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Application Due, Review and Anticipated Start Dates
Opening Date: November 17, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 17, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): December 17, 2009
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date: February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 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

3.B. Submitting an Application Electronically to the NIH

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

3.C. Application Processing

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

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

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

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

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements

Participation in the Annual Meetings of the Alliance:

CNTC PDs/PIs (or other designated senior investigators) will be expected to attend the annual Alliance PI Meeting and participate in CGC activities (if selected) to discuss their research progress. Funds to support travel of the PDs/PIs (and/or designated senior investigators, up to 2 persons per Center) to attend the annual Alliance PI meetings should be included in the application budget.

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

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

Organizational DUNS

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

PHS 398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan (Research Education Plan for R25 applications) component must be followed as outlined in the SF424 (R&R) Application Guide.

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

Appendix Materials

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

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

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.

2. SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI (or multiple PDs/PIs, if applicable) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.

4. Research & Related Budget: Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI (or multiple PDs/PIs, if applicable) must be included here.

B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

C. Equipment: self-explanatory.

D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program.

E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program (and their anticipated levels of effort in person-months).

F. Other Direct Costs: itemize as appropriate and allowed for the research education program.

K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.

5. PHS 398 Research Education Plan Attachments:

Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program.

If applicable, list relevant courses and/or research education/training activities that have already been conducted/implemented. In such cases provide, if available, such information as: (1) the number and demographics of participants/trainees (e.g., graduate students and post-doctoral fellows trained in areas relevant to this FOA in the applicants academic department(s) and/or in the laboratories of the proposed mentors; (2) number of participants/trainees, who transitioned to the next career phase and in what scientific areas; and (3) outcome-related data, such as publications, number of submitted and successful applications for fellowships and research awards, participants offered independent research positions or other measures of participant advancement to the next career level.

Part 5 of this section (Research Design and Methods) should be retitled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director/Principal Investigator (or multiple PDs/PIs, if applicable): Describe arrangements for administration of the program, provide evidence that the Program Director(s) is actively engaged in research and/or teaching in an area relevant to cancer nanotechnology and related to the mission of the NCI Alliance for Nanotechnology in Cancer, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.

Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NCI and the goals of the Alliance. Indicate any existing collaborations across mentors’ laboratories that may facilitate collaborative mentored research projects.

Proposed Research Education Program: Provide details on the proposed: (1) laboratory based mentored training; (2) workshops, seminars, and short courses; and (3) outreach activities.

(1) Outline the types and scope of the anticipated mentored research education/training laboratory projects. Provide overview of research directions in mentors’ laboratories that are amenable for the development of mentored research projects for the proposed CNTC. Discuss the potential for possible collaborative interactions across directions. Define the main didactic and research goals considered. Provide a tentative list of potential projects (or examples), defining their scientific aims. Discuss educational/training objectives and career development potential.

(2) Propose specific courses, seminars, workshops for development. Explain how each of the proposed items will advance the goals of the Alliance. Provide specific parameters (e.g., event duration, targeted audience, estimated number of participants, frequency for recurring events, etc.). Indicate sources of faculty to cover the proposed topical areas.

(3) Briefly describe plans to publicize the proposed Center and disseminate educational materials to scientific community and general public (including sharing the original content to be generated e.g., through the courses and other events sponsored by CNTC). This section will also serve as the required Dissemination Plan (see below).

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction. Applicants may wish to consult the NIH website (http://bioethics.od.nih.gov/) for additional guidance. An award cannot be made if an application lacks this component.

If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc. Specific names of potential participants are not required at the time of application.

Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Include (in a table) relevant data from other programs/efforts, listing, e.g., the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement, but not in consideration of the overall score. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NCI, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will not be reviewed.

Dissemination Plan: A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc. Applications that lack a dissemination plan will not be reviewed.

For applications submitted in response to this FOA, the description of the proposed Outreach Program (under Research Education Program Plan, see above) will serve as the Dissemination Plan.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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: Not Applicable

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which 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 (e.g., 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 (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

(d) Research education programs: These programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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

Applications that are complete and responsive to this 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 initial merit review, all applications will:

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

The 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.

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weight as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. These criteria are not listed in any order of priority.

Research education program grant applications submitted in response to this FOA should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs of the NCI in meeting its objectives. Applicants are strongly encouraged to contact NCI program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

Overall Impact/Priority Score. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research education program 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 proposed program).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific 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 proposed research education program address scientific/education areas and/or topics important to the mission of the NCI? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NCI?

Investigator(s). Are the PD/PIs, collaborators and other researchers appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI (or multiple PDs/PIs, if applicable) and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?

For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PD/PIs?

In addition, specific to this FOA: If multiple PD/PIs are proposed, do they represent complementary disciplines relevant to cancer nanotechnology with a potential for synergistic research?

Innovation. Is the research education program original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does this program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.

Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?

Environment. Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? Are the facilities, environment, and resources adequate and appropriate for the proposed research education program? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

Criteria for Specific Forms of Research Education/Training

(A) Laboratory Based Mentored Training: How relevant are the proposed activities in mentored laboratory based training to the overall goals of the Alliance? Are research programs currently conducted in the laboratories of the proposed mentors suitable to serve as a base for research education/training projects? How extensive is the experience of the proposed mentors in fostering career development of junior investigators? Are the scientific profiles of the proposed mentors sufficiently diverse to ensure multidisciplinary training? Are the proposed areas for training projects appropriate for collaborative, interactive studies? Are the targeted potential participants well matched to the proposed activities and the goals of the Alliance?

(B) Other Forms of Research Education Training: How useful will be the proposed short courses/workshops to the overall goals and activities of the Alliance? Are outreach activities well thought out to promote multidisciplinary cancer nanotechnology research? Is the dissemination plan to promote research education and training in cancer nanotechnology adequate for the goals of the Alliance? Will the proposed dissemination efforts facilitate trans-Alliance interactions and activities?

2.A. Additional Review Criteria:

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific 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.

Evaluation Plan: Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? If applicable, are the plans for obtaining feedback from participants adequate to measure the quality and effectiveness of the research education program?

Dissemination Plan: Is the dissemination plan strong and of high quality?

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.

2.B. 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/priority score.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the overall impact/priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the overall impact/priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will determine the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.

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 education program.

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.

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Research education programs: The initial review group will comment on the appropriateness of the proposed software dissemination plan.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

Selection of an application for award is not an authorization to begin performance. Any allowable costs incurred 90 days before the beginning (or start) date of the Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”

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 Institute to the grantee business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The research education program may not be transferred from one institution to another, unless strongly justified.

Consultation with the Institute program staff is strongly encouraged when a change of institution is being considered. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the Institute may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the NCI for review:

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Participation in Collaborative Activities of the Nanotechnology Alliance:

CNTC awardees will be expected to participate in the Alliance Coordination and Governance Committee (CGC). CGC will serve as the main governing board for the NCI Alliance for Nanotechnology in Cancer program. The committee will consist of: 1) one representative of each CCNE (one of the Center PIs), holding one vote, 2) four representative PIs of nanotechnology platforms (CNPPs), holding one vote each, 3) two representative PIs of nanotechnology training centers (CNTCs), holding one vote each (depending on the number of the awards, the ratio of votes from CCNE members to CNPP members to CNTC members will be adjusted to 4:2:1), and 4) two NCI Project Scientists, holding one vote each. Responsibilities of this committee will include sharing information and review of progress of the Alliance activities, development of collaborative research protocols, identifying technology impediments to clinical translation, and developing strategies for sharing technologies and validation results. CGC will meet three times a year (at least once in person at the annual PI meeting). The participation of CNTC representatives in the CGC is viewed as a way to enrich the respective research education training programs through the bidirectional feedback to and from other Alliance components.

3. Reporting

NOTE: This R25 programs requires a detailed budget annually, and therefore resulting awards will NOT be subject to the streamlined non-competing application process (SNAP).

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

The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award participants are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.

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 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: grodzinp@mail.nih.gov

Dr. Ming Lei
Cancer Training Branch
Center for Cancer Training
National Cancer Institute
6116 Executive Blvd, MSC 8346
Rockville, MD 20892
Telephone: (301) 435-9047
FAX: (301) 402-4472
Email: leim@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:

Amy Knight
Office of Grants Administration
National Cancer Institute
Fairview Center Building, Suite 300
1003 West 7th Street
Frederick, MD 21701-4106
Phone: (301) 846-6701
FAX: (301) 846-5720
E-mail: knighta@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 (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); 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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the 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/.

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

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.

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 SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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

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

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