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)

Title:Small Grants for Behavioral Research in Cancer Control (R03)

Announcement Type

This Funding Opportunity Announcement (FOA) replaces PAR-06-073, which was previously released November 15, 2005.

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

• October 6, 2008 - This PA has been reissued as (PAR-09-003).
• August 16, 2006 - See Notice NOT-CA-06-036 Publications are not to be included in applications and/or associated appendix materials submitted in response to these two program announcements.

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.

Program Announcement (PA) Number: PAR-06-458

Catalog of Federal Domestic Assistance Number(s)
93.399

Key Dates
Release/Posted Date: June 12, 2006
Opening Date: June 12, 2006 (earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): August 21, 2006; December 22, 2006; April 20, 2007; August 22, 2007; December 20, 2007; April 20, 2008; August 21, 2008; December 22, 2008.
Peer Review Date(s): November/December 2006; March/April 2007; July/August 2007; November/December 2007; March/April 2008; July/August 2008; November/December 2008; March/April 2009.
Council Review Date(s): February 2007; June 2007; October 2007; February 2008; June 2008; October 2008; February 2009; June 2009.
Earliest Anticipated Start Date(s): April 2007; July 2007; December 2007; April 2008; July 2008; December 2008; April 2009; July 2009.
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: December 23, 2008 (unless reissued).

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites behavioral research applications in cancer control from new investigators or established scientists refocusing their research interests to behavioral research in cancer. 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 behavioral cancer control research. Small grants are short-term awards to provide support for pilot projects, development and testing of new methodologies, secondary data analyses, and/or innovative studies that provide a basis for more extended research. Preliminary data is not required in these applications.

• This Funding Opportunity Announcement (FOA) will utilize the NIH small (R03) grant mechanism.
• The 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 mechanism is intended to support small research projects that can be carried out in short periods of time with limited resources.
• A budget for direct costs of up to $50,000 per year and a project duration of up to 3 years may be requested for a maximum of $100,000 direct costs over a 2- or 3-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.
• 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 and local governments; eligible agencies of the Federal government; domestic institutions/organizations; faith-based or community-based organizations; Indian/Native American Tribal Governments (Federally Recognized); Indian/Native American Tribal Governments (Other than Federally Recognized); and Indian/Native American Tribally Designated Organizations.
• Foreign institutions are not eligible to apply as primary applicants, but may collaborate with eligible domestic institutions.
• 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. Eligible applicants must be either new investigators who have not previously been Principal Investigator (PI) on a NCI cancer control research grant (R03, R01, U01, P01, R21), or established scientists refocusing their research interests to behavioral research in cancer. Predoctoral investigators currently enrolled in an accredited doctoral degree program also are eligible to apply if allowed by applicant organization. Candidates must be United States (U.S.) citizens, citizen nationals, or individuals lawfully admitted for permanent residence.
• 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 these 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

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. Submitting an Application Electronically 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

Section I. Funding Opportunity Description

1. Research Objectives

Purpose and background

The objective of the NCI Small Grants Program for Behavioral Research in Cancer Control is to provide support for new investigators or established scientists refocusing their research interests to behavioral research in cancer control. The award is designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of research expertise in behavioral cancer control research. The award provides support for pilot or feasibility studies, development and testing of new methodologies, development and testing of new research technology, secondary analysis of existing data, self-contained research projects, or innovative studies that provide a basis for more extended research (see also http://dccps.nci.nih.gov/smallgrants/). Examples of behavioral investigations in cancer control activities supported by this funding opportunity include, but are not limited to, the following areas:

Applied Cancer Screening

• Theory and methods development, effectiveness trials and related social, behavioral and health services research to promote the use of effective cancer screening tests, repeat screening, follow-up of abnormal findings and unscreened populations, as well as strategies for informed decision making regarding all cancer screening technologies in both community and clinical practice are appropriate. For additional information, go to http://dccps.nci.nih.gov/acsrb/priorities.html.

Basic and Biobehavioral Research

• Studies that examine mechanisms, principles, and theoretical underpinnings of cancer-related behavior change across ages, racial and ethnic groups, socioeconomic strata, and cancer diagnoses are appropriate.
• Research areas including, but not limited to: basic research in social, cognitive, and psychological processes (e.g., risk perception); biological mechanisms of psychosocial or behavioral processes related to cancer control (e.g., psychoneuroimmunology); decision processes involved in cancer prevention, detection, and treatment; methodology and measurement in behavioral science research; development and testing of models and theories of health behavior; psychosocial and behavioral consequences of cancer risk assessment; understanding processes and mechanisms underlying health communication; genetic and environmental influences on health behaviors related to cancer control; and mediators and moderators of adaptation and coping; are appropriate. For additional information, go to http://biobehavioral.cancer.gov.

Applied Research

• Applied health monitoring, methods, and outcomes research, including research related to evaluating patterns and trends in cancer-related behavioral risk factors, and determining the influence of those factors at the individual, societal, and systems levels on patterns and trends in measures of cancer burden, including incidence, morbidity, mortality, and survival; is appropriate. Innovative approaches that address surveillance of cancer-related behaviors using newly available data, linkage between existing data systems to create enriched data systems for cancer surveillance, and contemporary statistical and economic methods are encouraged. For additional information, go to http://appliedresearch.cancer.gov/.

Health Communication and Informatics Research

• Studies that examine the use of human and mediated communication, including the use of new communication technologies, in cancer prevention, control, and care, and also including persuasive communication campaigns, risk communication, information dissemination, social support, and coordination of care, are appropriate. Other examples may be found at http://dccps.nci.nih.gov/hcirb/about.html.

Health Disparities Research

• Studies that seek to explain the impact of ecological, socioeconomic, ethnic, and/or cultural factors on cancer incidence, morbidity, mortality, and survivorship in underserved communities, that assess the influence of cultural factors in the medical community, or that examine variations in treatment based on sociocultural factors, are appropriate. Additional information may be found at http://dccps.nci.nih.gov/od/healthdisp.html.

Health Promotion Research

• Studies to change current behaviors and/or bring about new behaviors, such as improved diet, increased physical activity, energy balance, obesity prevention, decreased virus exposure, skin cancer prevention (sun safety), and other behavioral risk factors relevant to reducing incidence, morbidity, or mortality from cancer, are appropriate. Cancer prevention research to change and maintain the health behaviors listed above, includes, but is not limited to, pilot studies, efficacy studies, and effectiveness studies that examine the individual, community, environmental, and/or policy factors that may affect the initiation or maintenance of cancer-related health behaviors. Methodology studies to test theory-driven models and the use of innovative technology to better understand the health behaviors listed above are also of interest. Other examples may be found at http://healthpromotionresearch.cancer.gov.

Survivorship

• Studies that examine the adverse and/or positive effects of cancer diagnosis and treatment or that aim to prevent or control negative outcomes, and/or enhance positive outcomes, such as resilience among cancer survivors and their families, are appropriate.
• Pilot investigations focusing on the development, delivery, and/or evaluation of interventions that carry the potential to improve the length and quality of survival from cancer are encouraged.
• Survivorship studies may also include behavioral, clinical, and/or epidemiological research on the prevalence and control of post-cancer morbidity, second cancers, and chronic diseases other than cancer, instrument development specific to cancer survivors, and analyses of the economic cost of cancer survivorship. Other examples may be found at http://survivorship.cancer.gov.

Surveillance Research

• Studies related to evaluating patterns and trends in cancer incidence, morbidity, mortality, and survival are appropriate.
• Innovative approaches that address surveillance using newly available data, linkage between existing data systems to create enriched databases for cancer surveillance, or contemporary statistical and economic methods are encouraged, and may include ecologic studies of the cancer burden among various population groups according to geographic, socioeconomic, and/or systems-level factors.
• Research that links population-based data on cancer to data on risk factors or health-related behaviors is appropriate. Research to develop statistical methodologies and/or statistical models for analyzing trends and for evaluating the impacts of cancer control interventions as well as of geographic, social, behavioral, genetic, and health care delivery factors on the cancer burden are appropriate. For additional information, go to http://surveillance.cancer.gov/.

Tobacco Control Research

• Tobacco use etiology, prevention, and cessation studies, including, but not limited to, pilot studies that test strategies for improving utilization of current technologies in high risk individuals and populations are appropriate.
• Studies assessing the effect of various policies on tobacco initiation and use as well as secondary data analyses of existing datasets are welcome. Additional examples may be found at http://tobaccocontrol.cancer.gov.

Additionally, investigators may propose high priority secondary analyses in these areas.

Although the specific study proposed may attempt only to obtain preliminary data and/or conduct pilot studies in support of a future, more detailed intervention study, it is important that a long-term human cancer control hypothesis and supporting scientific justification be presented.

Applications not fitting one of the program areas stated above will be returned to the proposed Principal Investigator (i.e., PI or applicant) without undergoing peer review.

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 institutes and centers (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; and/or
• Development of new research technology.

Among the requirements detailed in this FOA, R03 applications should describe:

• The 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 the research program; and
• 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

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 3 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 NCI 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 Local governments;
• Eligible agencies of the Federal government;
• Domestic institutions/organizations;
• Faith-based or community-based organizations;
• Indian/Native American Tribal Governments (Federally Recognized);
• Indian/Native American Tribal Governments (other than Federally Recognized); and/or
• Indian/Native American Tribally Designated Organizations.

Foreign institutions are not eligible to apply as primary applicants, but may collaborate with domestic institutions.

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 IC Web sites, and by consulting with NIH staff. All small grant R03 applications submitted in response to this FOA will be assigned to the NCI (and possibly to other NIH ICs) according to standard U.S. Public Health Service (PHS) referral guidelines and specific program interests.

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

To download an 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
• NIH eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm).

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Electronic Research Administration (eRA) Commons.

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

1) Organization/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) Organization/Institutional Registration in the eRA Commons

• To find out if an organization is already registered in the Commons, 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 Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.
• Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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 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
PHS398 Modular Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: June 12, 2006 (earliest date an application may be submitted to Grants.gov).
Application Submission/Receipt Date(s): August 21, 2006; December 22, 2006; April 20, 2007; August 22, 2007; December 20, 2007; April 20, 2008; August 21, 2008; December 22, 2008.
Peer Review Date(s): November/December 2006; March/April 2007; July/August 2007; November/December 2007; March/April 2008; July/August 2008; November/December 2008; March/April 2009.
Council Review Date(s): February 2007; June 2007; October 2007; February 2008; June 2008; October 2008; February 2009; June 2009.
Earliest Anticipated Start Date(s): April 2007; July 2007; December 2007; April 2008; July 2008; December 2008; April 2009; July 2009.

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically 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.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

• If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
• If the two day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

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 an 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 candidate should identify a mentor(s) with cancer prevention and control research expertise that has NIH grant experience and is willing to mentor junior investigators in behavioral research. The mentor is not required to be employed in the applicant s institution. The candidate should include a mentoring plan that describes the nature, frequency, and method of mentoring that will take place through the entire grant period. The plan should provide evidence of the mentor s commitment to mentoring, as seen in previous mentoring activities. The mentor s proposed percent effort commitment to the mentoring plan should also be stated.

In the budget requests, applicants should include costs for attendance at a single 2-day grantee meeting in Bethesda, Maryland, to which they, as principal investigators, will each be invited sometime during their second year of funding.

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 submitted in response to this FOA will use the NIH modular budget format and Just-in-Time concepts, with direct costs of up to two $25,000 modules or $50,000 in total per year, and a maximum of $100,000 over 2 or 3 years (i.e., four modules of $25,000 each in total over the entire award period) being allowed.
• 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 the mentoring plan, 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.

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant mechanisms allow the inclusion of publications.

• Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH PubMed Central (PMC) submission identification number. Do not include the entire article.
• Manuscripts accepted for publication, but not yet published: The entire article may be submitted electronically as a PDF attachment.
• Manuscripts published, but an online journal link is not available: The entire article may be submitted electronically as a PDF attachment.
• Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
• Graphic images of gels, micrographs, etc., provided that the image (may be reduced in size) is also included within the (stated) 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.

As stated before, applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan.

Applicants are reminded to review this FOA for program-specific guidance on Appendix material and other application requirements.

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

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NIH ICs on the basis of established PHS referral guidelines.

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.

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 appropriate national advisory council or 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.

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

2.B. Additional Review Considerations

Budget 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

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

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:

Veronica Chollette, R.N., M.S.
Applied Cancer Screening Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4100, MSC 7331
Bethesda, MD 20892-7331 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-435-2837
Fax: 301-480-6637
E-mail: [email protected]

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8634
Fax: (301) 496-8601
E-mail: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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.

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 U.S. 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/.

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