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: Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Year 2005-2006

Announcement Type
This is a reissue of PAR-03-158 which was previously released August 4, 2003

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-05-042

Catalog of Federal Domestic Assistance Number(s)
93.397, 93.121

Key Dates
Release Date: February 17, 2005
Letters of Intent Receipt Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: March 23, 2005
Skin and prostate cancer SPORE: July 23, 2005
Application Receipt Dates:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: May 23, 2005
Skin and prostate cancer SPORE: September 23, 2005
Peer Review Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: October 2005
Skin and Prostate Cancer SPORE: February 2006
Council Review Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: February 2006
Skin and Prostate Cancer SPORE: June 2006
Earliest Anticipated Start Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: February 2006
Skin and Prostate Cancer SPORE: June 2006
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: September 24, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The Organ Systems Branch of the Office of Centers, Training, and Resources, Office of the Director, National Cancer Institute invites grant applications for Specialized Programs of Research Excellence (SPOREs) in organ-specific cancers. Applicant institutions are to demonstrate their ability to conduct translational research in prevention, etiology, screening, diagnosis, and treatment of lung, genitourinary, prostate, or skin cancers. Translational research, as defined by the Program, 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. Required components of a SPORE include: a minimum of four translational research projects, cores, developmental research and career development programs. A required core in a SPORE is a human cancer tissue core for the particular organ-site that will benefit translational research. SPOREs foster extended collaborations in critical areas of research among laboratory and clinical or applied scientists. SPOREs are expected to have a robust research base in the respective cancer, good access to patient populations, and substantial commitment from their institution. Inter-SPORE collaborations and collaborations between SPOREs and other NIH programs are strongly encouraged. Each SPORE and the "network" of SPOREs are expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality of human cancer. Eligible organizations include: For-profit or non-profit domestic organizations, public or private institutions, such as universities, colleges, hospitals, and laboratories, Units of State and local governments, and eligible agencies of the Federal government, and faith-based or community-based organizations. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. The support for SPOREs is through an NIH specialized center grant (P50) mechanism.

The applicants will follow the instructions for the PHS 398 form (available at http://grants.nih.gov/grants/funding/phs398/phs398.html), the current Program Announcement (PAR), and SPORE Guidelines (at http://spores.nci.nih.gov/). For further assistance, contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Because of the size and complexity of a SPORE, prospective applicants are urged to consult with the staff of the Organ Systems Branch early in the preparation of the application (see Section VII. Agency Contacts). Special instructions are needed for preparing a SPORE application and are available from the program contact listed under Section VII. Agency Contacts, or at http://spores.nci.nih.gov/. This PAR addresses only SPORE applications for organ sites specified to be received in the year 2005.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

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

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

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

A SPORE maintains state-of-the-art research that will contribute to improved screening, detection, diagnosis, treatment, and prevention of an organ-specific cancer (or related group of cancers). SPOREs are expected not only to conduct a wide spectrum of research activities, but should also contribute significantly to the development of specialized research cores, improved research model systems, and collaborative research projects with other institutions. The research supported through this program must be translational in nature. Translational research involves the use of knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or to determine the biological basis for observations made in individuals with cancer or in populations at risk for cancer. Inherently, this process involves interdependence between investigators conducting basic and applied research. It should be noted that 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 purposes of this program.

See http://spores.nci.nih.gov/guidelines/guidelines.html for SPORE Guidelines.

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

Section II. Award Information

1. Mechanism of Support

A SPORE is supported through the specialized center (P50) grant mechanism. Applicants are solely responsible for planning, directing, and executing the proposed project. This mechanism provides funding for a broad range of research and developmental activities, from basic to human intervention studies. These grants are intended to promote multidisciplinary research focused upon a specific cancer (or related cancer) site(s). SPORE grants differ from traditional Program Project (P01) grants in that they also provide support for pilot research projects and a career development program, as well as enable investigators more flexibility to modify their research activities when new opportunities arise.

This funding opportunity uses just-in-time concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NCI policy for SPORE grants establishes the following limits to the requested budgets: new or competing renewal P50 SPORE applications may each involve a request for a maximum annual direct cost of up to $1.5 million and maximum annual total cost of $2.5 million. The facilities and administrative costs related to subcontracts to other institutions or organizations are included in the total cost cap of $2.5 million, but not in the direct cost cap of $1.5 million. Applications can exceed these caps in subsequent years as a result of standard cost-of-living increases or special supplements approved by NCI.

A SPORE grant application may be submitted for up to 5 years of funding. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Fiscal and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Eligible institutions may include foreign components as full research projects, or cores, or as part of a research project or core. SPOREs may also use developmental funds to establish collaborative research efforts with foreign entities. Consortia agreements with foreign institutions must include provisions that ensure adequate representation of women, minorities, and children in all research components that involve clinical trials or any other type of human intervention and must be in compliance with NIH policies.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the NIH Grants Policy Statement. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or cost_sharing.

3. Other Special Eligibility Criteria

SPORE applications must also have: (1) a statement of institutional commitment that addresses how the SPORE will be given high priority within the institution; (2) an intellectual property management plan: (3) a minimum of four independent principal investigators who are successful in obtaining peer-reviewed research support directly related to the cancer being investigated; (4) a minimum of four research projects, representing a balance and diversity of translational approaches; (5) shared cores designed to support the proposed translational objectives of the SPORE; (6) a developmental research program; and (7) a career development program. In addition, attendance at SPORE workshops and related meetings is required. Although an application can only be submitted by a single institution, subcontracted collaborative arrangements with scientists from other institutions may be included if these arrangements are clearly delineated and officially confirmed by signed statements from the responsible official at each institution. This circumstance, however, does not preclude the need for a full institutional commitment from the applicant organization.

GUIDELINES OF THE SPORE PROGRAM: The general components and procedures for preparing a SPORE application are outlined in this program announcement under Eligible Institutions, Application Processing, and Peer Review Process. SPECIAL GUIDELINES that address programmatic, review and award concerns in more detail, however, must be followed when preparing a SPORE application. SPORE GUIDELINES can be viewed at http://spores.nci.nih.gov/guidelines/guidelines.html.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: March 23, 2005
Skin and Prostate Cancer SPORE: July 23, 2005
Application Receipt Dates:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: May 23, 2005
Skin and Prostate Cancer SPORE: September 23, 2005
Peer Review Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: October 2005
Skin and Prostate Cancer SPORE: February 2006
Council Review Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: February 2006
Skin and Prostate Cancer SPORE: June 2006
Earliest Anticipated Start Date:
Lung and Genitourinary (bladder, kidney, testicular, not prostate) Cancer SPORE: February 2006
Skin and Prostate Cancer SPORE: June 2006

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to the Program Directors for the organ sites at the following address:

Jane Fountain, Ph.D.
Program Director (Skin Cancer SPOREs)
Email: jf227t@nih.gov

Peter Ujhazy M.D., Ph.D.
Program Director (Lung Cancer SPOREs)
Email: pu5s@nih.gov

Andrew Hruszkewycz M.D., Ph.D.
Program Director (Genitourinary and Prostate Cancer SPOREs)
Email: ah5x@nih.gov

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013, MSC 8347
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8528
Fax: (301) 402-5319

3.B. Sending an Application to the NIH

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435 0715

At the time of submission, two additional copies of the application must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Do NOT send Appendix material at this time. You will be contacted by the Scientific Review Administrator at a later date and the Appendices will be requested.

3.C. Application Processing

Applications must be received on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Applications will be evaluated for completeness by CSR and responsiveness by NCI. Incomplete or non-responsive applications will not be reviewed.

The NCI 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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

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 continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

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

6. Other Submission Requirements

Plan for Sharing Research Data

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

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

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

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). 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

Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness to the guidelines of this PAR by the NCI program staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

a. Research Projects

Within the SPORE concept of translational research (see definition in Section I.B. above), reviewers will evaluate each research project using the recently updated five review criteria (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html) and additional factors noted below. Each criterion will be considered by the reviewers in assigning the overall merit score of the project, although a project does not need to be strong in all criteria in order to be viewed as meritorious.

1. SIGNIFICANCE.
Does this study address an important translational research goal or barrier? Is it likely the study will be completed within the project period? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the impact of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If a project is ongoing, did it achieve its goals within the previous funding period; is scientific progress adequate?

2. 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? Is there clear evidence of co-leadership between both a basic biological and applied or clinical scientist in the conception, design, and proposed implementation of the project? Do the project co-leaders acknowledge potential problem areas and consider alternative tactics? If the project is ongoing and has changed research direction, is there appropriate rationale for the new approach?

3. INNOVATION.
Is the project original and innovative in the context of translational research? 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 organ site?

4. INVESTIGATORS.
Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level and time commitments of the co-leaders and co-investigators on the project? Does the investigative team bring complementary and integrated expertise to the project?

5. ENVIRONMENT.
Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit form unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? If applicable, is there evidence of effective use of SPORE cores?

For competing renewal applications , adequate progress should be demonstrated on projects that are ongoing. Any difficulties in achieving the previously proposed specific aims should be addressed and the new research goals should be logical extensions for the project. There should be clear evidence that such a project reached its anticipated human application(s) during the previous funding period and the continuation of the project will lead to new translational findings. It should also be evident that the investigative team, especially the project co-leaders, established a productive working relationship during the past performance period and have published or submitted manuscripts describing their previous findings.

b. Cores

1. Specimen core

2. Other Cores

c. Developmental Research Program

1. Adequacy of the process and/or track record for attracting new ideas and pilot studies within and outside of the SPORE institution. The outreach capabilities of a SPORE are often demonstrated within this program.

2. Adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects with translational research potential. For competing renewal applications, this program should also be evaluated by the SPORE's ability to promote outstanding translational pilot projects to full projects and/or demonstrate the successful competition of these projects for outside funds.

3. Appropriateness of the budget (whether derived entirely from the SPORE or a combination of sources) relative to the needs and demonstrated capabilities of the SPORE. A minimum of $50,000 direct costs per year must be allocated from SPORE funds.

d. Career Development Program

1. Adequacy of the process and/or track record for selecting promising candidates for independent careers (academic, industrial, governmental) in translational cancer research.

2. Adequacy of the procedures and/or track record to seek out and include qualified women and minorities.

3. For competing renewal applications, current status and research activities of individuals who have been supported by the career development program. This may include the promotion of outstanding career development projects to full projects within the SPOREs and involve the continuing support and integration of successful career development awardees as project co-leaders or co-investigators.

4. Appropriateness of the budget (whether derived entirely from the SPORE or a combination of sources) relative to the proposed plans for sustaining a significant effort in career development. A minimum of $50,000 direct costs per year must be allocated from SPORE funds.

e. Overall Program Organization, Interaction and Capability

1. Leadership

Scientific qualifications and involvement of the SPORE principal investigator as well as his/her demonstrated scientific and administrative leadership capabilities and time commitment.

2. Institutional Commitment

Adequacy of and/or demonstrated institutional commitment for facilitating the research objectives of the SPORE (e.g., special facilities, recruitments, discretionary resources such as dollars and space).

3. Integration within the SPORE and the Institution

Effectiveness of and/or plans for integrating the activities of SPORE projects with proposed cores, as well as integrating SPORE research and cores with existing Cancer Center/institutional resources (e.g., use of clinical data and safety management systems, biostatistical cores, etc.). SPORE projects are not required to interact with each other.

4. Cancer Patient Population

Adequacy of access to patients and populations for conducting current and projected therapeutic, prevention, detection, and control research. For competing renewal applications , documentation of accomplished translational goals, including evidence of human subjects enrollment on clinical/population research studies during the past funding period.

5. Planning and Evaluation of Activities

Adequacy of the plan and/or track record to evaluate the translational research productivity of existing projects and cores; discontinue activities of low productivity; initiate new activities in response to important translational research opportunities; establish collaborations; and utilize the advice of internal and external advisors.

6. Collaborations

Evidence of tangible interactions with other SPOREs and/or NIH/NCI Networks. Willingness to interact with other SPOREs and with the NIH/NCI in sharing information, participating in committees, and collaborating on activities of mutual interest. For competing renewal applications , contributions and outcomes from annual SPORE Workshop and other related SPORE or NIH/NCI meetings during the term of the award.

7. Intellectual Property Management Plan

Adequacy of a plan and/or track record for the management of intellectual property generated by SPORE projects. There should be evidence for the appropriate evaluation, protection, and commercialization of SPORE inventions. Engagement of the institution's technology transfer office should be documented and established or proposed assurances should be provided outlining any pre-existing agreements with commercial entities. Related or ongoing activities with industrial sponsors may also be discussed to demonstrate collaborative potential and provide assurance that the SPORE is poised to move human applications forward into the next appropriate clinical or population setting.

8. Data Management

Adequacy of and/or track record for the overall data management or bioinformatics capabilities of the SPORE as they related to the Cancer Center, institution, or activities of other NIH/NCI initiatives.

9. Progress (for Competitive Renewal Applications)

The progress and achievements specific to the application and relevant to translational research since the previous competitive review. Adequacy of the justification for adding new projects or cores or deleting previous components.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398.)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Overall Evaluation and Scoring of Applications: A single numerical priority score will be assigned to the SPORE application as a whole after discussing all of the review elements listed above. The score will be based on the overall quality of the research projects (using the SPORE definition of translational research in Section I.B.) and career development and developmental research programs, the overall effectiveness and adequacy of cores, the overall program organization and capability including plans or productivity of interactions with other SPOREs and/or NIH/NCI Networks.

The final overall priority score for the application will be weighted as follows:

70% scientific merit of the projects and shared cores, including the likelihood of achieving the proposed translational research objectives

30% overall programmatic organization and capabilities, including developmental programs (Career Development and Developmental Research)

If a required component(s) of an otherwise meritorious SPORE application is of such low merit that it is not recommended for further consideration (NRFC) by the peer review committee, the entire application will also receive a NRFC. See Section I.E. of SPORE GUIDELINES (http://spores.nci.nih.gov/) for a more detailed description of each of the required components of a SPORE.

2.C. Sharing Research Data

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

For SPOREs, this plan should be global in nature to include research data generated by projects and/or SPORE supported cores. If applicable, this plan should also discuss how model organisms generated through the SPORE will be shared (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). The plan should be presented in the Program Description.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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.

3. Anticipated Announcement and Award Dates
See Section IV.3.A.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

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

Principal Investigators whose proposals have been selected for award will be notified either by electronic mail or by postal mail.

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional officials, at the time of award.

2.A Cooperative Agreement Terms and Conditions
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. Also see SPORE Guidelines http://spores.nci.nih.gov/guidelines/guidelines.html.

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:

Jane Fountain, Ph.D.
Program Director (Skin Cancer SPORE)
Email: jf227t@nih.gov

Peter Ujhazy M.D., Ph.D.
Program Director (Lung Cancer SPORE)
Email: pu5s@nih.gov

Andrew Hruszkewycz, M.D., Ph.D.
Program Director (Genitourinary and Prostate Cancer SPOREs)
Email: ah5x@nih.gov

Organ Systems Branch
Office of Centers, Training, and Resources
Office of Deputy Director for Extramural Science
National Cancer Institute
6116 Executive Boulevard, Suite 7013, MSC 8347
Bethesda, MD 20892-8347
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8528
Fax: (301) 402-5319

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Judy Sint
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852-7150 (for express/courier service)
Telephone: (301) 496-7240
Email: sintj@nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

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/guide/notice-files/NOT-OD-04-042.html). 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Public 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 public 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 PA 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.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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