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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 2006

Announcement Type
This is a reissuance of PAR-05-042 , which was released on February 17, 2005.

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

Program Announcement (PA) Number: PAR-05-156

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

Key Dates
Release Date: August 18, 2005

Letters of Intent Receipt Date:
Breast Cancer SPORE: December 1, 2005
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: April 1, 2006
Head & Neck Cancer and Prostate Cancer SPOREs: August 1, 2006 (Now August 21, 2006 per NOT-CA-06-021)

Application Receipt Dates:
Breast Cancer SPORE: February 1, 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: June 1, 2006
Head & Neck Cancer and Prostate Cancer SPOREs: October 1, 2006 (Now September 20, 2006 per NOT-CA-06-021)

Peer Review Dates:
 Breast Cancer SPORE: June 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: October 2006
Head & Neck Cancer and Prostate Cancer SPOREs: February 2007

Council Review Dates:
 Breast Cancer SPORE: October 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: January 2007
Head & Neck Cancer and Prostate Cancer SPOREs: May 2007

Earliest Anticipated Start Dates:
 Breast Cancer SPORE: November 1, 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: April 1, 2007
Head & Neck Cancer and Prostate Cancer SPOREs: July 1, 2007

Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: October 2, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I. Overview Information

Part II. Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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
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/ and http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Interim_2005.pdf 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 request a maximum annual direct cost of $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.

The earliest anticipated start dates are as follows: Breast Cancer SPORE: November 1, 2006; Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: April 1, 2007; and Head & Neck Cancer and Prostate Cancer SPOREs: July 1, 2007.

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.

Facilities 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 (including the required human cancer tissue/specimen core for the particular organ site) ; (6) a developmental research program (with a minimum required budget of $50,000 in direct costs per year); and (7) a career development program (with a minimum required budget of $50,000 in direct costs per year). In addition, attendance of SPORE lead investigators (i.e., principal investigators, project leaders, core directors, and other key personnel) 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.

Applications must contain documentation regarding the appropriateness of requested budgets to conduct proposed services. All proposed cores must include a budgetary request from SPORE funds. For example, the appropriateness of the budget with regard to the conduct of activities related to the banking, analysis, and distribution of specimens must be discussed in the application. For both the developmental research program and for the career development program, the 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 and to the proposed plans for sustaining a significant effort in career development, respectively, must be documented; a minimum of $50,000 direct costs per year must be allocated from SPORE funds for each of those two programs.

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/ and http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Interim_2005.pdf.

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 application form and instructions. For further assistance, contact GrantsInfo, Telephone: (301) 710-0267: 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
See Section IV.3.A for details.

3.A. Receipt, Review, and Anticipated Start Dates

Letters of Intent Receipt Date:
Breast Cancer SPORE: December 1, 2005
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: April 1, 2006
Head & Neck Cancer and Prostate Cancer SPOREs: August 1, 2006

Application Receipt Dates:
Breast Cancer SPORE: February 1, 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: June 1, 2006
Head & Neck Cancer and Prostate Cancer SPOREs: October 1, 2006

Peer Review Dates:
 Breast Cancer SPORE: June 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: October 2006
Head & Neck Cancer and Prostate Cancer SPOREs: February 2007

Council Review Dates:
 Breast Cancer SPORE: October 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: January 2007
Head & Neck Cancer and Prostate Cancer SPOREs: May 2007

Earliest Anticipated Start Dates:
 Breast Cancer SPORE: November 1, 2006
Gastrointestinal (GI) Cancer, Brain Cancer, and Lymphoma SPOREs: April 1, 2007
Head & Neck Cancer and Prostate Cancer SPOREs: July 1, 2007

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 specified organ sites at the following address:

Rashmi Gopal-Srivastava, Ph.D.
Program Director (Breast Cancer SPORE)
Email: gopalr@mail.nih.gov

Ivan Ding, M.D.Program Director (GI and Head & Neck Cancer SPOREs)
Email: dingi@mail.nih.gov

Jane Fountain, Ph.D.
Program Director (Brain Cancer SPORE)
Email: fountai@mail.nih.gov

Peter Ujhazy M.D., Ph.D.
Program Director (Lymphoma SPOREs)
Email: ujhazyp@mail.nih.gov

Andrew Hruszkewycz, M.D., Ph.D.
Program Director (Prostate Cancer SPOREs)
Email: hruszkea@mail.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 (for U.S. Postal Service Express or regular mail)
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

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

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

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

Do NOT send Appendix materials 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/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This rule 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 NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 the NIH Grants Policy Statement at 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 (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at 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

Applications that are complete and responsive to the PA 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 following will be considered in making funding decisions:

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 the Executive Summary and in Part II, Section I.1. above), reviewers will evaluate each research project using the five review criteria below and additional factors noted further 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 (this human cancer tissue/specimen core for the particular organ site is a required component of a SPORE).

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.

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.

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. 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.

8. 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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

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 as provided in the Executive Summary and in Part II, Section I.1. above) 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 percent: scientific merit of the projects and shared cores, including the likelihood of achieving the proposed translational research objectives; and

30 percent: 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 (go to http://spores.nci.nih.gov/ and to http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Interim_2005.pdf) 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. 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 (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at 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. 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 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 Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the 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).

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 at http://spores.nci.nih.gov/ and at http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Interim_2005.pdf.

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:

Rashmi Gopal-Srivastava, Ph.D.
Program Director (Breast Cancer SPORE)
Email: gopalr@mail.nih.gov

Ivan Ding, M.D.
Program Director (GI and Head & Neck Cancer SPOREs)
Email: dingi@mail.nih.gov

Jane Fountain, Ph.D.
Program Director (Brain Cancer SPORE)
Email: fountai@mail.nih.gov

Peter Ujhazy M.D., Ph.D.
Program Director (Lymphoma SPOREs)
Email: ujhazyp@mail.nih.gov

Andrew Hruszkewycz, M.D., Ph.D.
Program Director (Prostate Cancer SPOREs)
Email: hruszkea@mail.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 (for U.S. Postal Service Express or regular mail)
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 (for U.S. Postal Service Express or regular mail)
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, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service Express or regular mail)
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); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: (1) currently funded NIH research projects or (2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see: http://www.lrp.nih.gov/.

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NIH Funding Opportunities and Notices


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