Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Years 2013 and 2014 (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of PAR-10-003

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-12-296

Companion Funding Opportunity

None

Number of Applications

Each applicant institution may submit multiple SPORE applications provided that they are scientifically distinct, proposed in a different cancer organ site and are led by different PDs/PIs. A single investigator may participate in more than one SPORE as long as there is no scientific overlap. Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.397, 93.393, 93.394, 93.395, 93.396, 93.399, 93.121, 93.853

Funding Opportunity Purpose

The National Cancer Institute (NCI), the National Institute of Dental and Craniofacial Research (NIDCR), and the National Institute of Neurological Disorders and Stroke (NINDS), at the National Institutes of Health (NIH), invite applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPOREs). The program will fund 5-year P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer (or a related group of cancers). SPOREs are expected not only to conduct a wide spectrum of research activities, but also to contribute significantly to the development of specialized shared resource core facilities (cores), improved research model systems, and collaborative research projects with other institutions. The research supported through this program must be translational in nature and must always be focused upon knowledge of human biology stemming from research using cellular, molecular, structural, biochemical, and/or genetic experimental approaches with the goal of a translational human endpoint within the 5 year term of the grant. In addition, SPOREs must include both a Developmental Research Program for pilot studies and a Career Development Program to foster careers in organ-based translational science.

Key Dates
Posted Date

September 25, 2012

Letter of Intent Due Date

30 days before the due date

Application Due Date(s)

January 24, 2013; May 21, 2013; September 20, 2013; January 21, 2014; May 20, 2014; September 23, 2014

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2013; September/October 2013; January/February 2014; May/June 2014; September/October 2014; January/February 2015;  

Advisory Council Review

October 2013; January 2014; May 2014; October 2014; January 2015; May 2015

Earliest Start Date(s)

April 2014; April 2014; July 2014; April 2015; April 2015; July 2015

Expiration Date

(Now Expired December 12, 2013 per issuance of PAR-14-031), Originally September 24, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The National Cancer Institute (NCI), the National Institute of Dental and Craniofacial Research (NIDCR), and the National Institute of Neurological Disorders and Stroke (NINDS), at the National Institutes of Health (NIH), invite applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPOREs) in organ-specific or groups of highly related cancers. This Funding Opportunity Announcement (FOA) targets applicant institutions with demonstrated ability to conduct translational research in the prevention, early detection, diagnosis, and/or treatment of human cancer. Applications may address cancer in any organ site, but each application must be organ site specific or address cancers that are related. Examples include (but are not limited to) leukemias, lymphomas, myelomas, sarcomas, and cancers of brain, breast, gastrointestinal (GI) system, bladder, kidney, cervix, endometrium, head & neck, lung, ovary, pancreas, prostate, skin, oral cavity & pharynx, eye & orbit, and endocrine system. Applicants are encouraged to consult with the Translation Reseach Program (TRP) staff members regarding the focus of their application.

For the SPORE program, the NCI defines translational research as follows:

"Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer."

The term "interventions" is used in its broadest sense to include molecular assays, imaging techniques, drugs, biological agents, and/or other methodologies applicable to the prevention, early detection, diagnosis, prognosis, and/or treatment of cancer. SPORE translational research projects may involve the use of any cellular, molecular, structural, biochemical, and/or genetic experimental approaches.

The SPORE program fosters highly interactive translational research based on a unique approach with the following characteristics:

Inherent in this process is the interdependence between investigators conducting basic and applied research. Clinical and/or epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human cancer is not considered translational for the SPORE.

The minimum effort for the Program Director/Principle Investigator (PD/PI) on a SPORE grant is 2.4 person months. Note that SPOREs must be led by a single PD/PI, i.e. SPOREs are prohibited from having multiple PD(s)/PI(s). Each applicant institution may submit multiple SPORE applications provided that they are scientifically different, proposed in a different cancer sites, and are led by different PDs/PIs. A single investigator may participate in more than one SPORE as long as there is no scientific overlap.

For the latest SPORE Guidelines and other information about this program, go to NCI- Translational Research Program (TRP) http://trp.cancer.gov/.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Approximately 8-12 SPORE awards per each of the 2 years of this FOA are anticipated. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Award Budget

Applicants may request a maximum of $2,500,000 total costs/year for each of 5 years. The facilities and administrative (F&A) costs related to subcontracts to other institutions or organizations as well as the grantee organization are included in the total cost cap of $2.5 million.  Please note that in accordance with NIH Policy NOT-OD-12-036, cost of living escalations are not allowed.

Award Project Period

The maximum period is 5 years.

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individual (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. The PD/PI on a SPORE grant must contribute a minimum effort of 2.4 person months. This level of effort needs to be maintained during the entire award period. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Multiple PD(s)/PI(s) are not permitted for a SPORE grant. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted according to the NIH Policy on Resubmisison Application from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

SPORE Guidelines

For more detailed instructions on the content and form of the application please see the the SPORE Guidelines.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

It is also helpful if the letter of intent includes the titles of the anticipated projects and cores of the SPORE. The letter of intent should be sent to:

Rajeev K. Agarwal, Ph.D.
Program Director
Translational Research Program (TRP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
9609 Medical Center Drive, Room 3W120
Bethesda, MD 20892-9726 (regular mail)
Rockville, MD 20850 (express/courier mail)
Telephone: 240-276-5688
Fax: 240-276-7881
Email: agarwalraj@mail.nih.gov

Application Submission

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-1115

At the time of submission, two additional paper copies of the application and a copy of the Appendix materials on a CD must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Introduction (only for resubmission applications; 1 page limit for each scored section.

Program Overview (1 page Specific Aims, 30 page limit)

POC: Program Organization and Capability (12 page limit)

SC: Scientific Collaboration (12 page limit)

Translational Research Projects (1 page Specific Aims, 12 page limit for research strategy)

Shared Resource Cores (1 page Specific Aims, 12 page limit for core services strategy)

Developmental Research Program (DRP) (1 page Specific Aims, 12 page limit)

Career Development Program (CDP) (1 page Specific Aims, 12 page limit)

Application Section Descriptions  

Face Page (PHS 398 Form Page 1): Type "SPORE" in the top left hand corner of the face page immediately above the words "GRANT APPLICATION." Check the "yes" box in Item 2 and enter PAR-12-296 "SPOREs in Human Cancer for Years 2013 and 2014 (P50)." Complete all other items on the face page of the application according to the PHS 398 instructions; all succeeding pages should be numbered consecutively.

Reminder: Multiple PD(s)/PI(s) are not permitted for a SPORE grant (Item 3).  

Items 7 and 8: Although there is no indirect cost budget cap, by NCI policy, all competing SPOREs (both new and renewal applications) are subject to a total cost budget cap of $2.5 million. Total costs include all direct and indirect costs from all participating institutions. Consortium indirect costs must be included in the total costs. Applications with requests exceeding this limit may be delayed in the review process or not reviewed. In non-competing years, budget requests can no longer allow for annual cost-of-living increases (NOT-OD-12-036).  

Description/Project Summary, Performance Sites and Key Personnel (PHS 398 Form Page 2): Follow the PHS 398 instructions for completing the Project Summary, Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells.  

The Project Summary/Description serves as a succinct and accurate description of the overall SPORE when it is separated from the application. State the SPORE's broad, long-term objectives and specific aims. State the contribution of each component project, shared resource core, and the developmental programs to the translational research goals of the SPORE. The second component of the Description is Relevance. Using no more than two or three sentences, describe the relevance of the work proposed in the overall SPORE to public health. Use plain language that can be understood by a general, lay audience.  

Under Performance Sites, list the applicant institution and all other sites where work proposed in the SPORE will be conducted. The names of involved institutions should be spelled out in full for the first mention with the acronym in parenthesis. The acronym may be used subsequently. The Key Personnel list for the entire SPORE should begin with the PD/PI, followed alphabetically by all leaders/directors, co-leaders, co-investigators, consultants and consortium collaborators involved in all projects, developmental programs, and shared resource cores, whether receiving salary or not, who will provide effort and/or significant intellectual input into the proposed research. List other personnel who will be other collaborators or consultants under "Other Significant Contributors."  

Table of Contents (PHS 398 Form Page 3): Instead of using the Table of Contents page in the PHS 398 form, which is primarily for single project R01 applications, use PHS 398 Continuation Pages to prepare a Table of Contents following the format shown in Appendix A of the SPORE Guidelines.

Budget for Overall SPORE (Form Pages 4 and 5): Prepare a detailed composite budget for all requested support categories including projects, cores, and developmental programs, for the first year using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS398 application.

Reminder: Budget requests for renewal  SPORE grant applications must also not exceed a total cost (direct plus indirect cost) of $2.5 million.  

Biographical Sketches: Place all the Biographical Sketches together in one section following the overall budget for the program. Place the biographical sketch of the PD/PI first, followed by the biographical sketches of all other personnel in alphabetical order. It is helpful if each person is identified by listing the project, shared resource core or developmental program in the upper left corner of the biographical sketch. Do not repeat biographical sketches in the individual components of the SPORE, e.g. projects, cores, developmental programs.  

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Program Overview  

The Program Overview section should summarize the overall goals and research strategies for the entire SPORE. Page limits for each section of the Program Overview are given below.   

Introduction to the Overall Application: (Resubmission applications only) - One page limit.  

Overall SPORE Goals and Specific Aims: (One page limit)  State the organ site cancer(s) to be studied and succinctly list the specific objectives and goals of the SPORE as a whole. Summarize the expected outcomes(s) of the SPORE as a whole, including the impact that the results of the proposed translational research will have on prevention, early detection, diagnosis and/or treatment of organ-site specific cancer. Applications with a focus on organ sites of breast, lung, GI and prostate are required to propose at least one project on early detection, prevention, and/or population science. Other organ site SPOREs are encouraged to include these types of projects though they are not required.

Overall Research Strategy - (Thirty page limit)  Summarize the Overall Research Strategy, including the SPORE's overall significance, overall innovation, overall approach, preliminary studies, and progress (for renewal applications.) References and a list of publications are not included in the 30 page limit.  Additional details about the content of the Program Overview Section are provided in the Guidelines for SPORE (http://trp.cancer.gov).

Program Organization and Capabilities (POC)  

Introduction: (Resubmission applications only; one page limit)

POC Body: (Twelve page limit) Succinctly address each of the following items - leadership, institutional commitment, integration within the SPORE and the institution, cancer patient population, data management, and planning and evaluation activities. Additional details about the content of the POC section are provided in the Guidelines for SPORE (http://trp.cancer.gov).  

Required Statements and Letters of Support: Place all institutional statements and letters of support relative to the overall SPORE after the Program Organization and Capabilities section. 

Overall Program Environment and Resources: Use the Resources Format page in the PHS 398 instructions and continuation pages to briefly summarize the overall institutional environment and resources that are relevant to effective implementation of the SPORE. This may include NCI-supported clinical and laboratory facilities, participating and affiliated units, patient population, geographic distribution of space and personnel, consultative resources, and relevant collaborations with investigators currently funded under other mechanisms. Additional details about the content of the Overall Program Environment and Resources section are provided in the Guidelines for SPORE (http://trp.cancer.gov).  

Scientific Collaboration (SC)

Describe (12 page limit) collaborative efforts of SPORE projects within the SPORE community, across NCI-supported clinical trial and translational science mechanisms, and also with other government and non-government programs. Include introduction (one page) for resubmission applications. Additional details regarding the content of the SC section are provided in the SPORE Guidelines.

Individual Research Projects  

Shared Resource Cores  

Developmental Research Program (DRP)

Career Development Program (CDP)

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification :

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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 theNIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

A grantee may, at his/her 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 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 or renewal award.

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

6. Other Submission Requirements and Information

SPORE applications have additional submission requirements, which are described in more detail in the GUIDELINES OF THE SPORE PROGRAM, available at http://trp.cancer.gov.  Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed except under exceptional circumstances.  

SPORE applications have the following additional submission requirements, which are described in more detail in the SPORE Guidelines.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115. with the following modification:      

Section V. Application Review Information

1. Criteria

Overall Impact

Reviewers will provide an overall impact/priority score on a 9-point scale (1=exceptional; 9=poor)) to reflect their assessment of the likelihood that the SPORE as a whole will exert a sustained, powerful impact on translational cancer research, in consideration of the following five review criteria and additional review criteria for the individual projects and Cores, developmental programs, POC, and SC listed below (as applicable). 

Review Criteria - For Overall SPORE

Reviewers will consider, but not individually score, each of the five review criteria below in the determination of the overall scientific and technical merit of the SPORE.  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 SPORE as a whole address an important translational research problem or a critical barrier to progress in the field?  If the aims of the SPORE are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the SPORE change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PI, collaborators, and other researchers well suited to the SPORE?  If investigators are in the early stages of independent careers or are new to translational cancer research, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  Do the investigators have complementary and integrated expertise for proposed collaborations; are their leadership approaches, governance and organizational structure appropriate for the SPORE? Are the qualifications and experience of the PD/PI and other senior scientists appropriate for the work proposed?  Do they provide effective scientific, administrative, and collaborative leadership, as demonstrated by selection of individual projects for scientific excellence and translational feasibility?  Have they established effective developmental programs for pilot studies as well as for building careers in translational research in organ-site specific cancers?  Is the commitment of the PD/PI and other senior investigators adequate?

Innovation

Does the overall SPORE challenge and seek to shift current research or clinical practice paradigms in the context of translational research for a particular organ site by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Does the SPORE seek out high risk/high payoff projects that are based on solid preclinical preliminary studies, and that have a good chance of achieving a human endpoint within the five year funding period?

Approach

Are the overall strategies, methodologies, and analyses, including biostatistical methods well-reasoned and appropriate to accomplish the specific aims of the SPORE? Are potential problems, alternative strategies, and milestones for success presented?  If any of the projects are in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed so that the 5 year goal of a human endpoint can be achieved?  Are there plans for collaboration? What is the overall quality of the projects and the adequacy of services provided by the shared resource cores (if proposed)?  Has there been demonstration of both horizontal and vertical collaboration? Are the plans for protection of human subjects from research risks, and inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?  Is the institutional commitment to the SPORE, as well as support, equipment and other physical resources available to the program adequate for the projects, cores, and developmental programs  proposed? If more than one institution is involved in the SPORE, in what way will the institutions act synergistically to implement the goals of the SPORE?  Will the program benefit from unique features of the scientific environment, subject populations, or overall collaborative arrangements?

Review Criteria for Individual Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. A project 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. An assigned reviewer will give a criterion score for each of the following five criteria for the individual research projects. However, criterion scoring is not used for the other SPORE components.

Significance

Does the project address an important translational research goal or barrier for this particular organ site or the related group of cancers? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigators

Are the Project co-leaders, collaborators, and other researchers well suited to the project?  Is there adequate evidence of co-leadership of the project by basic and applied/clinical investigators in the conception, design, and proposed implementation of the project?  If investigators are in the early stages of independent careers or are new to translational cancer research do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative with other groups, do the investigators have complementary and integrated expertise; are their leadership approaches, governance and organizational structures appropriate for the project?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Will the research achieve a human endpoint within the five year project period?  Is it likely the study will be completed within the project period?  If the project is ongoing and has changed research direction, is there appropriate rationale for the new approach?  Are the plans for (1) protection of human subjects from research risks and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Note: Aspects of collaboration unrelated to scientific data will be reviewed in the SC section and not in the SPORE Research Projects section.

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? In the case of multiple institutions involved in a single SPORE, is there an adequate plan for communication among investigators to achieve the goals of the grant?  Is there evidence of institutional support? Is there evidence of effective use of SPORE Cores?

Review Criteria for Shared Resource Core(s)

Each Shared Resource Core must provide essential functions or services for at least one project.

Note: Criterion scoring is not used for these SPORE components; strengths and weaknesses will be listed. 

1. Administrative Core (required)

2. Biospecimen/Pathology Core (required)

3. Other Cores (optional)

Review Criteria for the Developmental Research Program (DRP)

(Note: Criterion scoring is not used for this SPORE component; strengths and weaknesses will be listed.)

Review Criteria for the Career Development Program (CDP)

(Note: Criterion scoring is not used for this SPORE component; strengths and weaknesses will be listed.)

·         Is the proposed plan to select promising candidates for independent careers (academic, industrial, governmental) in translational cancer research adequate?  Is the plan for recruitment, retention and communication with awardees adequately addressed?  For renewal applications, are the research activities, independent grant awards, publication(s), and promotion/current status of individuals who have been supported by the CDP addressed? 

Review Criteria for Overall Program Organization and Capabilities (POC)

(Note: Criterion scoring is not used for this SPORE component; strengths and weaknesses will be listed.)

1. Leadership

Are the scientific qualifications, involvement, leadership and time commitment of the PD/PI sufficient for requirements of the proposed SPORE? (Leadership for collaborations will be reviewed in the SC section.)

2. Institutional Commitment

Is the institutional commitment for facilitating the research objectives of the SPORE (e.g., through special facilities, recruitments, discretionary funding, supplemental resources for CDP and DRP) documented and sufficient?

3. Integration within the SPORE and the Institution

Are the activities of SPORE projects and proposed cores well integrated? Does the entire SPORE integrate with the existing cancer center/institute (e.g., use of clinical data and safety management systems, biostatistical and other cores, etc.)? Is there evidence of, or plans for, coordination and communication across all components of the SPORE and among all participating institutions at the overall SPORE level?

4. Cancer Patient Population

Is the access to patients and populations for conducting current and projected therapeutic, prevention, detection, and control research adequate to ensure likely success of the SPORE?  For renewal applications, documentation of accomplished translational goals, including evidence of human subject enrollment on clinical/population research studies (if applicable) during the current funding period should be provided.

5. Data Management

Are the plans for, and/or track record of, the overall data management and/or bioinformatics capabilities of the SPORE as they are related to the Cancer Center, institution, and/or activities of other NIH/NCI initiatives sufficient for the requirements of the proposed SPORE?

6. Planning and Evaluation Activities

Are the plans for and/or track record of evaluating the translational research productivity of existing projects and COREs adequate for the requirements of the proposed SPORE?  Are the plans for and/or track record of use of advice from internal and external advisors sufficient?  For renewal applications, is there evidence that the flexibility available to the SPORE has been used effectively?

Review Criteria for Scientific Collaboration (SC)

(Note: Criterion scoring is not used for this SPORE component; strengths and weaknesses will be listed.)

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period

Suggestions for Renewal applications are included within each of the SPORE sections above.

The main aspects to address include the following points:.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. SPORE applicants should be aware that competitive revision awards to SPOREs are rare and require compelling situations.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider 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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignments to review groups will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Toby T. Hecht, Ph.D.
Associate Director
E-mail: hechtt@mail.nih.gov

Rajeev K. Agarwal, Ph.D.
Program Director (Gastrointestinal [GI], Pancreas and Skin Cancer SPOREs)
E-mail: agarwalraj@mail.nih.gov

Julia T. Arnold, Ph.D.
Program Director (Brain and Ovarian Cancer SPOREs)
E-mail: jarnold@mail.nih.gov

Andrew Hruszkewycz, M.D., Ph.D.
Program Director (Prostate and Genitourinary [Kidney and Bladder] Cancer SPOREs)
E-mail: hruszkea@mail.nih.gov

Igor Kuzmin, Ph.D.
Program Director (Breast and Gynecologic [Cervical and Endometrial] Cancer SPOREs)
E-mail: kuzmini@mail.nih.gov

Steven F. Nothwehr, Ph.D.
Program Director (Lymphoma, Leukemia and Myeloma SPOREs)
E-mail: nothwehrs@mail.nih.gov

Peter Ujhazy M.D., Ph.D.
Program Director (Head & Neck, Sarcoma, and Lung Cancer SPOREs)
E-mail: ujhazyp@mail.nih.gov

Translational Research Program (TRP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
9609 Medical Center Drive, Room 3W110
Bethesda, MD 20892-9726 (regular mail)
Rockville, MD 20850 (express/courier mail)
Telephone: 240-276-5730
Fax: 240-276-7881

Contact one of the program officials listed above for organ sites not mentioned.

Program staff at co-sponsoring NIH institutes:

Jane W. Fountain, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
6001 Executive Blvd
Rockville, MD 20892-9521
Telephone: (301)496-1431
FAX: (301) 402-2060
E-mail: fountai@ninds.nih.gov

Sundar Venkatachalam, Ph.D.
Program Director
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health (NIH)
6701 Democracy Blvd., Room 625
Bethesda, MD 20892-4878
Phone: (301)594-4812
Fax: (301) 480-8319
E-mail: sundarv@nih.gov

Peer Review Contact(s)

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive
Room 7W412, MSC 9750
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Shane Woodward
Branch Chief, DCTD Grants Branch
Office of Grants Administration (OGA)
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 2W462
Rockville, MD 20850
Telephone: 240-276-6303
Fax: 240-276-6300
E-mail: woodwars@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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