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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.cancer.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

Title: Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Years 2010, 2011 and 2012 (P50)

Announcement Type
This is a reissue of PAR-08-020

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-003

Catalog of Federal Domestic Assistance Number(s)
93.397, 93.393, 93.394, 93.395, 93.396, 93.121, 93.853

Key Dates
Release Date: October 2, 2009
Letters of Intent Receipt Dates: December 28, 2009; April 20, 2010; August 21, 2010; December 20, 2010; April 20, 2011; August 20, 2011; December 20, 2011; April 22, 2012; August 20, 2012
Application Receipt Dates: January 28 2010 (changed to February 26, 2010 per NOT-CA-10-017); May 20, 2010; September 21, 2010; January 20, 2011; May 20, 2011; September 20, 2011; January 20, 2012; May 22, 2012; September 20, 2012
Peer Review Dates: May/June 2010; September/October 2010; January/February 2011; May/June 2011; September/October 2011; January/February 2012; May/June 2012; September/October 2012; January/February 2013
Council Review Dates: October 2010; January 2011; May 2011; October 2011; January 2012; May 2012; October 2012; January 2013; May 2013
Earliest Anticipated Start Dates: December 2010; April 2011; July 2011; December 2011; April 2012; July 2012; December 2012; April 2013; July 2013
Additional Information: To Be Available Date (URL Activation Date): Not applicable
Expiration Date: September 21, 2012

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 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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

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

For the SPORE program, the NCI defines translational research as follows: translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer. The term "interventions" is used in its broadest sense to include molecular assays, imaging techniques, drugs, biological agents, and/or other methodologies applicable to the prevention, early detection, diagnosis, prognosis, and/or treatment of cancer. SPORE translational research projects may involve the use of any cellular, molecular, structural, biochemical, and/or genetic experimental approaches.

The SPORE grant mechanism (P50) fosters highly interactive translational research based on a unique approach with the following characteristics:

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

For the SPORE Guidelines and other information about this program, go to http://trp.cancer.gov/.

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 NIH 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 site or a related group of cancers. 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 flexibility to modify their research activities when new opportunities arise.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The NCI policy for SPORE grants establishes the following limits to the requested budgets: new or renewal P50 SPORE applications may each request a maximum annual total cost of $2.5 million. The facilities and administrative (F&A) costs related to subcontracts to other institutions or organizations are included in the total cost cap of $2.5 million. Applications may exceed this cap in subsequent years by standard cost-of-living increases (3%) or special supplements approved by NCI.

A SPORE grant applicant may request up to 5 years of funding.

Approximately 8-12 SPORE awards per each of the 3 years of this FOA are anticipated. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions and organizations are not eligible to apply for P50 SPORE grants.

However, eligible domestic 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 research 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 his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement but it is both allowed and encouraged.

3. Other-Special Eligibility Criteria

Number of Applications. Each applicant institution may submit multiple SPORE applications provided that they are scientifically different, proposed in a different cancer site and are led by different PIs. A single investigator may participate in more than one SPORE as long as there is no scientific overlap.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. Applicants who submitted applications prior to January 25, 2009 and are not funded, may resubmit in accord with NIH Resubmission policies, but must utilize the new application forms and instructions with a restructured and shorter Research Plan.

Renewals. Applicants may submit a renewal application.

Section IV. Application and Submission Information

1. Address to Request Application Information

The most current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

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 in item (box) 2 of the face page of the application form and the YES box must be checked.

Form Page 1 - Face Page Type "SPORE" in the top left hand corner of the face page immediately above the words "GRANT APPLICATION." Check the ?yes? box in Item 2 and enter PAR-10-003, ?Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Years 2010, 2011 and 2012 (P50).? Complete all other items on the face page of the application according to the PHS 398 instructions; all succeeding pages should be numbered consecutively.

Reminder: Multiple PD/PIs are not permitted for the SPORE grant (Item 3).

Items 7 and 8: Although there is no indirect cost budget cap, by NCI policy, all competing SPOREs (both new and renewal applications) are subject to a total cost budget cap of $2.5 million. Total costs include all direct and indirect costs from all participating institutions. Consortium indirect costs must be included in the total costs. Applications with requests exceeding this limit may be delayed in the review process or not reviewed. In non-competing years, budget requests can exceed the cap for annual cost-of-living increases (less than or equal to 3% of direct costs).

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

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

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

Form Page 3 - Table of Contents

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

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

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

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

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

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

Overall SPORE Goals and Specific Aims - One page limit. State the organ site cancer(s) to be studied and succinctly list the specific objectives and goals of the SPORE as a whole. Summarize the expected outcomes(s) of the SPORE as a whole, including the impact that the results of the proposed translational research will have on prevention, early detection, diagnosis and/or treatment of organ-site specific cancer.

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

Program Organization and Capabilities (POC)

Introduction: (Resubmission applications only) - One page limit.

Succinctly address each of the following items - Twelve page limit

Leadership, institutional commitment, integration within the SPORE and the institution, cancer patient population, collaborations, data management, and planning and evaluation activities.

Additional details about the content of the POC section is provided in the Guidelines for SPORE (http://trp.cancer.gov).

Required Statements and Letters of Support

Place all institutional statements and letters of support relative to the overall SPORE after the Program Organization and Capabilities section.

Overall Program Environment and Resources

Use the Resources Format page in the PHS 398 instructions and continuation pages to briefly summarize the overall institutional environment and resources that are relevant to effective implementation of the SPORE. This may include NCI-supported clinical and laboratory facilities, participating and affiliated units, patient population, geographic distribution of space and personnel, consultative resources, and relevant collaborations with investigators currently funded under other mechanisms.

Additional details about the content of the Overall Program Environment and Resources section is provided in the Guidelines for SPORE (http://trp.cancer.gov).

Multiple PI Leadership Plan - More than one Program Director/Principal Investigator may not be designated by the applicant organization to direct the overall SPORE.

Individual Research Projects

Introduction (Resubmission applications only) ? One page limit

Specific Aims ? One page limit

Research Strategy- Twelve page limit

Each SPORE must include at least four translational research projects with at least two project co?leaders per project (one basic and one clinical or applied).

Additional information on the content of the Individual Research Projects is provided in the Guidelines for SPORE (http://trp.cancer.gov).

Shared Resource Cores

Introduction to the Shared Resource Core (Resubmission applications only) ? One page limit

Specific Aims - One page limit

Core Services Strategy ? Twelve page limit for each core

For the SPORE a Biospecimen/Pathology Core is required. Other cores such as Administrative, Biostatistics, Clinical, Bioinformatics, and Animal cores, may also be proposed.

For additional information about shared resource cores see the Guidelines for SPORE (http://trp.cancer.gov).

Developmental Research Program (DRP)

The DRP is a required component of a SPORE.

Introduction to the DRP (Resubmission applications only) -One page limit

Specific Aims ? One page limit

DRP Plans for the SPORE with examples ? Twelve page limit

Clearly describe the process for solicitation of DRP projects and the institutional review process for awarding 2 year (or less) pilot projects that generate feasibility data.

Additional details about the content of the DRP and what is required for this section in renewal applications is provided in the Guidelines for SPORE (http://trp.cancer.gov).

Career Developmental Program

The CDP is a required component of a SPORE.

Introduction to the CDP (Resubmission applications only) ? One page limit

Specific Aims - One page limit

CDP Plans for the SPORE with examples ? Twelve page limit

Clearly describe the plans for this program including the policies, criteria, and processes for selecting candidates (e.g., advanced post-doctoral fellows, junior faculty, and established investigators), including the special efforts that will be made to recruit qualified women and minorities. Support of a CDP awardee should not exceed 2 years.

Additional information on the content of the CDP and what is required for this section in renewal applications is provided in the Guidelines for SPORE (http://trp.cancer.gov).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Dates: December 28, 2009; April 20, 2010; August 21, 2010; December 20, 2010; April 20, 2011; August 20, 2011; December 20, 2011; April 22, 2012; August 20, 2012
Application Receipt Dates: January 28 2010; May 20, 2010; September 21, 2010; January 20, 2011; May 20, 2011; September 20, 2011; January 20, 2012; May 22, 2012; September 20, 2012
Peer Review Dates: May/June 2010; September/October 2010; January/February 2011; May/June 2011; September/October 2011; January/February 2012; May/June 2012; September/October 2012; January/February 2013
Council Review Dates: October 2010; January 2011; May 2011; October 2011; January 2012; May 2012; October 2012; January 2013; May 2013
Earliest Anticipated Start Dates: December 2010; April 2011; July 2011; December 2011; April 2012; July 2012; December 2012; April 2013; July 2013

3.A.1. Letter of Intent

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

It is also helpful if the letter of intent includes the titles of the anticipated projects and cores of the SPORE.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent electronically or by mail to the NCI Program Officer/Director at the following address:

Rajeev K. Agarwal, Ph.D.
Program Director
Translational Research Program (TRP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6116 Executive Boulevard, Suite 700
Bethesda, MD 20892-8347 (regular mail)
Rockville, MD 20852 (express/courier mail)
Tel: 301-496-8528
Fax: 301-402-5319
Email:[email protected]

3.B. Sending an Application to the NIH

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
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 and all copies of the appendix material 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 non-USPS express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
E-mail: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt/ 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept one resubmission application, but such application must include an Introduction addressing the critique from the previous review. In addition, applicants who submitted applications prior to January 25, 2009 and are not funded, may resubmit in accord with NIH Resubmission policies, but must utilize the new application forms and instructions with a restructured and shorter Research Plan. Also note there are changes in other parts of the application including the Biographical Sketch and Resources sections.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at his/her own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements

SPORE applications have the following additional submission requirements, which are described in more detail in the GUIDELINES OF THE SPORE PROGRAM, available at http://trp.cancer.gov.

(1) Statement of Institutional Commitment

An institution applying for a SPORE grant should demonstrate a commitment to the proposed SPORE's stability and success by promising to incorporate the SPORE, if awarded, high within its institutional priorities. The application must provide a statement of commitment that includes a plan addressing how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPORE research effort will be given a high priority within the institution (relative to other research efforts). The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the SPORE Director, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, President, and Vice President for Research) and the Cancer Center Director should be attached confirming this commitment. In the case of a SPORE that involves a consortium arrangement between two or more institutions, the applicant institution that submits the SPORE application must receive a formal written agreement(s) from the other participant organization(s) which clearly delineates in what specific manner the participating institution plans to demonstrate a commitment to the SPORE, as well.

The primary institution (as well as any participating institutions) is strongly encouraged to demonstrate commitment by providing financial support to the Developmental Research and Career Development Programs on an awarded SPORE, as well as other programmatic needs identified as high priority on the application. Up to $50,000 of the SPORE direct costs budget per year may be requested for use as discretionary funds by the PI. The institution(s) is encouraged to match this request. These funds can be used to support anticipated, as well as unanticipated, activities, such as a clinical trial in year 2, pre-clinical testing of an agent in year 3, etc. Discretionary funds should be justified in detail and requested in the Administrative Core, if proposed, or in another appropriate project or core if an Administrative Core is not proposed. All financial commitments made by the institution to the SPORE will be monitored and are expected to be maintained during the entire term of the award.

(2) Cancer Patient Population

Each SPORE must document access to a substantial patient population in the cancer-site focus of the application and provide reasonable assurance that the patients and human specimens needed for translational research are readily available. If the appropriate patient population is not available at the applicant institution, a consortium agreement may be established with a different institution to provide adequate access to clinical specimens (e.g., tissues, blood, and urine) and/or patients at another site.

(3) Minimum Research Support Base

In order for a SPORE application to be accepted by NCI, the application must include four or more independent investigators who currently serve as PIs (or project leaders) on peer-reviewed research grants (e.g., R01, R21, P01, U01, U10, American Cancer Society [ACS], U.S. Department of Defense [DOD], or equivalent) or are overall chairpersons or site chairpersons on active NCI cooperative group clinical trial(s) or committees directly related to the cancer(s) being investigated. PIs supported by the NCI through K05, K22, K24, or K25 career development grants can also be included in the research base requirement if the career award is directly relevant to the cancer being investigated on the SPORE. Please note that an investigator who is a PI on multiple qualified grants or clinical trials counts only once towards the research base and, in order to qualify, the investigator must be the PI (not co- investigator) on the highlighted activity. The qualifying investigators also must have a significant role on the SPORE (i.e., greater than or equal to a 0.6 calendar months level of effort contributed as a project co-leader, co-investigator, or core director); they cannot only serve as mentors within the proposed Career Development Program or be the project leader of a proposed Developmental Research project. Applicants should confirm with TRP staff that they meet the minimum research base before preparing an application and again directly prior to submission of the application.

(4) Research Projects

A minimum of four research projects, which represent a balance and diversity of translational approaches is required.

(5) Shared COREs

Shared COREs are designed to support the proposed translational objectives of the SPORE (including the required biospecimen/pathology CORE for the particular organ site). COREs should not duplicate existing shared resources.

(6) A developmental research program (DRP)

Every SPORE must allocate significant effort and resources (with a minimum required allocated budget of $50,000 in direct costs per year) to support pilot projects that take maximum advantage of new research opportunities. Such projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE community. The applicant should propose an institutional review process for funding pilot projects that generate feasibility data and have the most promising translational research potential.

(7) A career development program (CDP)

The SPORE must demonstrate a consistent and significant commitment to the CDP in translational cancer research (with a minimum required allocated budget of $50,000 in direct costs per year). Funds from this program may be used to support junior faculty or established investigators who wish to develop or refocus their careers on translational research. This program is not a training program and does not support pre- or post-doctoral fellows, either pre-clinical or clinical. However, advanced post-doctoral or clinical fellows who provide a letter from an institution stating that the candidate will be joining its faculty within the next year are eligible for this program. Investigators supported by NCI career development awards (K series) may also be eligible for support through this program.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only, and . include five identical CDs in the same package with the application (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of cancer research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

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: (1) the expected schedule for data sharing; (2) the format of the final dataset; (3) the documentation to be provided; (4) whether or not any analytic tools will also be provided; (5) 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 (6) the mode of data sharing (e.g., under their own auspices by mailing a compact disk or posting data on their institutional or personal web site, through a data archive or enclave). Investigators who choose 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.

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

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

NIH policy expects that grant 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

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

A. Review Criteria for Overall SPORE

Significance. Does the SPORE address an important translational research problem or a critical barrier to progress in the field? If the aims of the SPORE are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

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

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the SPORE? Are potential problems, alternative strategies, and milestones for success presented? If there are projects in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed so that the 5 year goal of a human endpoint can be achieved? What is the overall quality of the projects and the adequacy of services provided by the shared resource cores (if proposed)? In the case of multiple institutions involved in a single SPORE, is there an adequate plan for communication among investigators to achieve the goals of the grant? For renewal applications, has there been adequate progress during the current funding period and have the projects reached a human endpoint or are they about to? Is there evidence of effective use of SPORE cores? Are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

The scientific projects and their associated shared resource cores are weighted approximately 70% of the overall impact/priority score and the developmental programs and the POC are weighted approximately 30% of the overall impact/priority score.

B. Review Criteria for Individual Research Projects

Reviewers will provide an impact score for each project that reflects their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria and additional review criteria. A project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Additional Criteria for SPORE Research Projects

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

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

Innovation. Does the project challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Is the project original and innovative in the context of translational research for the organ site(s) involved? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research (e.g. gene therapy specifically for one type of cancer) or novel in a broad sense (e.g. molecular targeting of a pathway known to be involved in many different cancers)? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Will the research achieve a human end-point within the requested project period? If the project is ongoing and has changed research direction, is there appropriate rationale for the new approach? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are the plans for (1) protection of human subjects from research risks and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

C. Review Criteria for Shared Resource CORE(s)

1. Biospecimen/pathology CORE (required).

2. Other COREs (optional).

D. Review Criteria for the Developmental Research Program (DRP)

Will the proposed plan for the DRP attract new ideas and pilot studies within and/or outside of the SPORE institution(s)? Is the plan for periodic review and funding of a spectrum of pilot projects, as well as for promoting pilot projects with translational research potential to full projects within the SPORE, adequate?

For renewal applications, did the DRP generate a strong publication record? Were any high-risk/high-impact projects funded through the DRP? Did data produced by the DRP lead to success in the competition for outside funds? Did any DRP projects reach translational potential and become full SPORE projects? Was funding from DRP used for collaborative projects with other institutions/programs?

E. Review Criteria for the Career Development Program (CDP)

F. Review Criteria for Overall Program Organization and Capabilities (POC)

1. Leadership

Are the scientific qualifications, involvement, leadership and time commitment of the PI sufficient for requirements of the proposed SPORE?

2. Institutional Commitment

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

3. Integration within the SPORE and the Institution

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

4. Cancer Patient Population

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

5. Collaborations

Is there a plan or evidence of interactions with other SPOREs, NIH/NCI programs and/or other organizations? Is sharing of information, participation in committees, or collaboration on other activities of mutual interest evident and sufficient? For competing renewal applications, are there contributions and outcomes from interSPORE collaborations, and other partnerships and team efforts that might have resulted from attendance at the NCI Translational Science Meeting and other related SPORE or NIH/NCI meetings during the term of the award?

6. Data Management

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Components from Foreign Organizations. SPORE applications from foreign organizations are not permitted. However, if a component of the SPORE is from a foreign organization, reviewers will assess whether the project or resource presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

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

Section VI. Award Administration Information

1. Award Notices

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

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

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.

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.

2. Administrative and National Policy Requirements

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

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

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:

Toby T. Hecht, Ph.D.
Associate Director
E-mail: [email protected]

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

Julia T. Arnold, Ph.D.
Program Director (Brain and Ovarian Cancer SPOREs)
E-mail: [email protected]

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

Igor Kuzmin, Ph.D.
Program Director (Breast and Gynecologic [Cervical and Endometrial] Cancer SPOREs)
E-mail: [email protected]

Steven F. Nothwehr, Ph.D.
Program Director (Lymphoma, Leukemia and Myeloma SPOREs)
E-mail: [email protected]

Peter Ujhazy M.D., Ph.D.
Program Director (Head & Neck, Sarcoma, and Lung Cancer SPOREs)
E-mail: [email protected]

Translational Research Program (TRP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6116 Executive Boulevard, Suite 700, MSC 8347
Bethesda, MD 20892-8347 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS express/courier delivery)
Telephone: (301) 496-8528
Fax: (301) 402-5319

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

Program staff at co-sponsoring NIH institutes

Jane W. Fountain, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
6001 Executive Blvd
Rockville, MD 20892-9521
Telephone: 301-496-1431
FAX: 301-402-2060
Email: [email protected]

Yasaman Shirazi, Ph.D.
Program Director
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health
45 Center Drive, Room 4AN-18C
Bethesda, MD 20892-6402
Phone: 301-594-4812
FAX: 301-480-8319
Email: [email protected]

2. Peer Review Contacts:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities (DEA)
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
E-mail: [email protected]

3. Financial or Grants Management Contacts:

Carol Perry
Team Leader, DCTD Grants Branch
Office of Grants Administration (OGA)
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7800
Fax: (301) 496-8601
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement 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.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the 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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigators NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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

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NIH Funding Opportunities and Notices


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