Part I Overview Information

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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)

Title: Cancer Prevention Research Small Grant Program (R03)

Announcement Type
This is a reissue of PAR-04-147, which was previously released August 18, 2004.

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

• December 17, 2007 - This PA has been reissued as (PAR-08-055).

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below); and

2) Applicants must complete a verification step in the eRA Commons within 2 business days of notification from NIH. Note: Since e-mail can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

Program Announcement (PA) Number: PAR-06-313

Catalog of Federal Domestic Assistance Number(s)
93.393

Key Dates
Release/Posted Date: April 4, 2006
Opening Date: May 2, 2006 (earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s): July 20, 2006; November 20, 2006; March 20, 2007; July 21, 2007; December 20, 2007.
Peer Review Date(s): October/November 2006; February/March 2007; June/July 2007; October/November 2007; February/March 2008.
Council Review Date(s): January/February 2007; May/June 2007; September/October 2007; January/February 2008; May/June 2008.
Earliest Anticipated Start Date(s): April 2007; July 2007; December 2007; April 2008; July 2008.
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: December 21, 2007.

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The Division of Cancer Prevention of the National Cancer Institute (NCI) invites applications that address developmental research in chemoprevention agent development, biomarkers, early detection, and nutrition science. However, it is important to note that this funding opportunity does not include applications that are focused on treatment, etiology, or treatment-related quality of life studies that are population based. This Small Grants Program is designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of research expertise in cancer prevention research. It is anticipated that this Small Grant Program may lead to the submission of subsequent individual research project grants (R01).

• This Funding Opportunity Announcement (FOA) will utilize the NIH Small (R03) grant mechanism.
• The NIH R03 grant mechanism supports different types of projects including: pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.
• The R03 is intended to support small research projects that can be carried out in a short period of time with limited resources.
• Budgets for direct costs of up to $50,000 per year and a project duration of up to 2 years may be requested for a maximum of $100,000 direct costs over a 2-year project period.
• Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications; therefore, the anticipated number of awards is not known.
• 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. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
• Eligible organizations include: for-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State governments; units of State Tribal governments; units of local governments; units of local Tribal governments; eligible institutions of the Federal Government; domestic institutions and organizations; foreign institutions and organizations; and faith-based or community-based organizations.
• Eligible Project Directors/Principal Investigators (PDs/PIs): 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.
• New, as well as experienced, investigators in relevant fields and disciplines (e.g., chemoprevention, nutritional science, genetics, infectious agents, and early detection, including biomarker development and validation) may apply for small grants to test ideas or do pilot studies.
• Applicants may submit more than one application, provided each application is scientifically distinct.
• See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:

• http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc (MS Word); and
• http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf (PDF).

• For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites:

• SF424 (R&R) Application and Electronic Submission Information at http://grants.nih.gov/grants/funding/424/index.htm; and
• General information on Electronic Submission of Grant Applications at http://era.nih.gov/ElectronicReceipt/.

• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

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

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

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

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Section I. Funding Opportunity Description

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1. Research Objectives

Purpose and background

This program is designed to aid and facilitate the growth of a cadre of scientists with expertise in cancer prevention research. Small grants are short-term awards that provide support for pilot projects, development and testing of new methodologies, or innovative projects that provide a basis for more extended research.

The NCI Division of Cancer Prevention invites applications that address developmental research in chemoprevention agent development, biomarkers, early detection, and nutrition science, in addition to clinical studies that focus on specific target organs. This scientific initiative (funding opportunity) is not intended for the support of research grant applications that are focused on treatment, etiology, and/or treatment-related general quality of life studies that are population-based. The specific areas of research may include, but are not limited to:

Early Detection

• Identification, development, and evaluation of biological analytic techniques, methodologies, and clinical technologies relevant to pre-clinical cancer detection and prevention of primary and recurrent cancers;
• Cellular, molecular, and genetic tumor markers;
• Molecular epidemiology and genetic risk factors;
• Imaging technology;
• Identification of molecular signatures of cancer-associated infectious agents for earlier cancer detection and risk assessment;
• Transfer of basic laboratory findings into applications for early detection with the goal of extending this research to comparative clinical trials;
• Development and evaluation of new high-throughput genomic- and proteomic-based detection techniques as well as of measures of sensitivity, specificity, validity, and safety;
• Performance of translational research to facilitate the transfer of new technologies (to the clinical setting) for earlier detection, prevention, and risk assessment;
• Development and evaluation of computer-based data monitoring systems for analysis and interpretation of laboratory data on multiple markers of and for the development of modeling systems based on molecular, genetic, and other risk factors to be used in the evaluation of cancer prevention approaches;
• Definition and evaluation of prognostic factors of pre-cancerous lesions by computer models that include neural networks, artificial intelligence, and other techniques; and
• Development of analytic techniques to identify populations that may be at increased risk as indicated by genetic and metabolic phenotypes (susceptibility markers).

Chemoprevention

• Pilot testing and development of new methods of chemoprevention, dietary, or nutrition intervention;
• Development and evaluation of molecular targets to prevent, reverse, or retard progression of precancerous lesions (and, hence, the cancer process) by natural, synthetic, chemopreventive agents;
• Feasibility and efficacy testing of rapid screening methods to identify and prioritize new chemopreventive agents;
• Testing of new strategies to prevent cancer or its progression in persons at increased genetic risk;
• Development of innovative animal models to mimic the human cancer process in order to expedite research in cancer prevention; and
• Investigation of mechanisms of action of chemopreventive agents.

Nutrition

• Improvements in methodology development for assessing nutritional status, metabolic patterns, and dietary modulation of genetic expression;
• Identification, development, and validation of biochemical or biological markers for measuring and monitoring dietary compliance and exposure;
• Development of reliable methods for analysis of nutrients, other dietary components, and their metabolites in foods, body fluids, and tissues;
• Development of mechanistic studies of dietary constituent interactions, gene-nutrient interactions, and dietary environmental factor interactions;
• Identification and evaluation of molecular targets to prevent, reverse, or retard progression of precancerous lesions (and, hence, the cancer process) by dietary/nutritional interventions;
• Determination of bioavailability and dose-response of foods, nutrients, and other naturally-occurring food constituents; and
• Although the specific study proposed may attempt only to obtain preliminary data and/or conduct pilot studies in support of a future, more detailed clinical study, it is important that a long-term human cancer prevention hypothesis and supporting scientific justification be presented.

Summary of Scientific Initiative

This program is designed to increase the basic and applied scientific knowledge of cancer prevention research, and to enhance community-based clinical research in cancer prevention.

Scope of Funding Mechanism

The common characteristic of the NIH R03 small grant is provision of limited funding for a short period of time. Examples of the types of projects that NIH ICs support with the R03 include the following:

• Pilot or feasibility studies;
• Secondary analysis of existing data;
• Small, self-contained research projects;
• Development of research methodology;
• Development of new research technology;
• Nature of the research opportunity;
• Pertinent background information that establishes the need for the research;
• Scientific knowledge to be achieved through research supported by the special program;
• Objectives of this research program; and
• Identify the types of research and experimental approaches that are being sought to achieve the objectives.

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

Section II. Award Information

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1. Mechanism of Support

This FOA will use the NIH Small Grants Program (R03) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total budget may not exceed $100,000 in direct costs for the entire project. The direct costs in any one year must not exceed $50,000. Please note that facilities and administrative [F&A] costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).

The total project period for an application submitted in response to this program announcement may not exceed 2 years. NIH policy limits the number of amendments that may be submitted to two. The small grant is not renewable.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

2. Funds Available

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 NIH Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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.

Facilities and Administrative (F&A) 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:

• For-profit organizations;
• Non-profit organizations;
• Public or private institutions, such as universities, colleges, hospitals, and laboratories;
• Units of State governments;
• Units of State Tribal governments;
• Units of local governments;
• Units of local Tribal governments;
• Eligible agencies of the Federal Government;
• Domestic institutions and organizations;
• Foreign institutions and organizations; and
• Faith-based or community-based organizations.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Not applicable. This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Investigators wishing to apply for an R03 grant should be aware that not all NIH ICs accept investigator-initiated R03 applications and that the different NIH ICs may have specific purposes for which they use this funding mechanism. Therefore, all investigators should consult the R03 Web site at http://grants.nih.gov/grants/funding/r03.htm as well as the NIH IC staff listed on this Web site to determine if an R03 application is appropriate.

Information related to the use of R03 awards by NIH ICs that do not participate in this FOA is also listed on the R03 Web site. Additional information about special initiatives involving R03 awards can be found by searching the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/index.html#search, by examining NIH IC Web sites, and by consulting with NIH staff.

Applicants may submit more than one application, provided each application is scientifically distinct. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Section IV. Application and Submission Information

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

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

• Grants.gov (http://www.grants.gov/GetStarted); and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm).

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

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

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional 1 to 2 business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  E-mail [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  E-mail [email protected]

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

• The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Signing Official (SO) or their designee who is already registered in the Commons.
• Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify the application.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

For further assistance, contact GrantsInfo; Telephone: 301-710-0267, E-mail: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

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

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

• Charge back of customs and import fees is not allowed.
• Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
• Funds for up to 8 percent administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

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

Opening Date: May 2, 2006 (earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s): July 20, 2006; November 20, 2006; March 20, 2007; July 21, 2007; December 20, 2007.
Peer Review Date(s): October/November 2006; February/March 2007; June/July 2007; October/November 2007; February/March 2008.
Council Review Date(s): January/February 2007; May/June 2007; September/October 2007; January/February 2008; May/June 2008.
Earliest Anticipated Start Date(s): April 2007; July 2007; December 2007; April 2008; July 2008.

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Electronic Transmission an Application to the NIH

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

3.C. Application Processing

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

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the SO for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:

• R03 applications will use the modular budget format and Just-in-Time concepts, with direct costs of up to two $25,000 modules, or $50,000 per year, may be requested for up to 2 years (i.e., a maximum of $100,000 over 2 years in four modules of $25,000 each).
• Items 2-5 of the PHS398 Research Plan component of the R03 application may not exceed 10 pages, including tables, graphs, figures, diagrams, and charts.
• Introduction (required for a resubmission application) is limited to one page.
• Preliminary data are not required, but may be included if available.
• R03 Appendix materials may include graphic images of gels, micrographs, etc., provided that the image (may be reduced in size) is contained within the 10-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.
• Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

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

Plan for Sharing Research Data
Not applicable.

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/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan 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). See Section VI.3., Reporting.

Section V. Application Review Information

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1. Criteria

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

2. Review and Selection Process

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit either by appropriate CSR-managed initial review groups (i.e., study sections) or by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
• Receive a written critique; and
• Receive a second level of review by the National Cancer Advisory Board

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:

• Scientific merit of the proposed project as determined by peer review;
• Availability of funds; and
• Relevance to program priorities.

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.

• Significance
• Approach
• Innovation
• Investigator
• Environment
• Additional Review Criteria

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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

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 item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not applicable.

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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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), See Section VI.3., Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

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1. Award Notices

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

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

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 e-mail notification from the awarding component to the grantee 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 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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

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

Section VII. Agency Contacts

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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:

Padma Maruvada, Ph.D. (Early Detection)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3144, MSC 7362
Bethesda, MD 20892-7362 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-3893
E-mail: [email protected]

Harold Seifried, Ph.D. (Nutrition)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3160, MSC 7328
Bethesda, MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-8573
E-mail: [email protected]

Vernon Steele, Ph.D., M.P.H. (Chemoprevention)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2117, MSC 7322
Bethesda, MD 20892-7322 (for U.S. Postal Service express or regular mail)
Rockville, MD 2085 2 (for express/courier delivery)
Telephone: 301-594-0420
E-mail: [email protected]

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 delivery)
Telephone: (301) 496-3428
Fax : (301) 402-0275
E-mail: [email protected]

3. Financial or Grants Management Contacts:

Shane Woodward
Office of Grants Administration
National Cancer Institute
Fairview Center Building, Suite 300
1003 West 7th Street
Frederick, MD.21701-4106
Telephone: 301-846-1017
FAX: 301-846-5720
E-Mail: [email protected]

Section VIII. Other Information

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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).

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); 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://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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 Web site (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 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 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/.