Part I Overview Information

Department of Health and Human Services (DHHS)

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
National Cancer Institute (NCI), (

Title: Exploratory Grants for Behavioral Research in Cancer Control (R21)

Announcement Type
This is a reissue of PA-04-034, which was previously released December 11, 2003.

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

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


This FOA must be read in conjunction with the application guidelines included with this announcement in for Grants (hereafter called

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: PA-06-351

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release/Posted Date: April 12, 2006
Opening Date: May 2, 2006 (earliest date an application may be submitted to
NOTE: On time submission requires that applications be successfully submitted to no later than 5:00 p.m. local time (of the applicant institution/organization).
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s):
AIDS Application Receipt Date(s):
Peer Review Date(s):
Council Review Date(s):
Earliest Anticipated Start Date(s):
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: May 2, 2009 (now May 8, 2009 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The purpose of this funding opportunity announcement (FOA) is to encourage exploratory and developmental research projects (R21) grant applications in the cancer control research continuum (i.e., primary prevention to end of life care) from investigators representing a range of behavioral and social science disciplines. With this FOA, the Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites the submission of R21 grant applications that describe research projects that will utilize developmental and exploratory approaches to primary and secondary cancer prevention and control. Research areas may include: cancer health and risk communication; enhancing cancer survivorship; promoting healthy diet and physical activity; prevention and control of tobacco use; interaction between psychosocial and biological mechanisms; cancer screening behaviors; and palliative and end-of-life care.

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. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The evolution and vitality of the biomedical and behavioral/social sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the NIH exploratory/ developmental R21 grant mechanism, the NCI seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risks, but may lead to breakthroughs in specific areas, and/or to the development of novel techniques, agents, methodologies, models, and/or applications that could have major impacts on fields of biomedical, behavioral, and/or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at

The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites the submission of behavioral research applications in cancer control from investigators from a wide range of behavioral and social science disciplines who wish to focus their research on the behavioral aspects of the cancer control continuum from prevention to end of life care. This grant is a 2-year award designed to encourage exploration of new ideas and new methodologies in the target area and to provide support for the collection of pilot data to be used as the basis for later R01 applications. This FOA is, therefore, intended to stimulate developmental and exploratory approaches to primary and secondary cancer prevention, prevention of cancer-associated morbidity, quality of life, communication, and health promotion behavioral research through a program of R21 grants. Because this developmental/exploratory grant mechanism is designed to support the collection of pilot data, and to allow an avenue for the exploration of new concepts and new methodologies, preliminary data as evidence of feasibility are not required. The applicant does have the responsibility for developing a sound research plan with a strong theoretical or empirical basis. Feasibility of the proposed research and potential significance for ongoing research are major considerations in the evaluation. Research may occur in a variety of settings, such as hospitals, universities, cancer centers, communities, schools, health departments, and worksites. It is appropriate to look at different populations within those settings and their interactions with cancer care health systems.

Applications should include justifications of study designs, methods, and sample sizes. In addition, applicants should identify the underlying conceptual or theoretical framework used and clearly indicate the significance of the research and where it will lead. Interdisciplinary research and research that includes integrative conceptual models are encouraged. Studies may focus on: a) assessment (instrumentation methods, measurement development, particularly in new research populations); b) intervention (feasibility of new and innovative approaches, appropriateness for use in populations disproportionately burdened with cancer or in populations involving other clinical, organizational, and community settings); c) dissemination (applications, sustainability); d) surveillance (issues of inclusion of minority populations, data base linkage studies to monitor progress toward cancer prevention and control); and e) biological and psychological influences on cancer and cancer-related behaviors. This grant mechanism is appropriate for testing timely interventions in pilot studies for feasibility or using rigorous qualitative research methods to assess the potential efficacy of an intervention. It is also appropriate for the psychometric evaluation of new measures or culturally appropriate ones to be adapted for use in populations where measures have not yet been developed or validated.

The Behavioral Research Program (BRP) and the Office of Cancer Survivorship (OCS) support research on a range of topics that are applicable to this FOA, and the following list is illustrative rather than comprehensive.

1. Enhancing the role of communication and informatics in improving cancer prevention and control and coordinating cancer care:

As new technologies are integrated into mainstream medical care and personal use, patients, physicians, and caregivers are being challenged to make difficult decisions in the face of uncertain risks and benefits. Research is needed in a changing health information environment that will focus on valid and reliable methods to develop and evaluate strategies to improve prevention, treatment and the coordination of cancer care among providers, patients and informal caregivers. The role(s) of communication strategies in easing transitions along the cancer care continuum from prevention to end of life should be studied. We need to illuminate the role that informatics can play in organizing health care teams to maximize patient outcomes and quality of care as well as creating real time feedback systems for enhancing health outcomes in primary and secondary prevention. There is also a need to create new behavioral and psychosocial models which offer more effective communication channels in a diverse society with multiple levels of the understanding of cancer risk and treatment. Research studies on communication patterns as a measure of patient-centered treatment, as well as research to redesign existing communication processes to impact client satisfaction, health status, and quality of life, are encouraged. There is a need to create communication and informatics applications that can enhance the value of personal health records so that they can be used as educational as well as medical tools. Research is also needed to understand the effects of media coverage and treatment of cancer-related topics on the knowledge, attitudes, and behavior patterns of both individuals and social groups.

2. Enhancing Survivorship of Cancer Patients:

Due to advancements in early detection and treatment, people are living longer with cancer, dramatically increasing the number of cancer-affected life-years in our nation. This raises the question of the quality of that extended survival time, including its effect upon productivity, the family functioning, and both medical and psychiatric comorbidities. There are now a number of under-studied cancer sites (e.g., liver, pancreatic, hemolytic cancers) and under-studied minority populations for which survivors are of interest. New behavioral and psychosocial interventions targeted to these populations are needed. There has been little work done using the family or the extended family as the unit of analysis, and looking at the long-term effect of the cancer experience on that unit. Research is also needed to: enhance functional health status (e.g., return to work); improve coping and adjustment to the effects of cancer and its treatment; improve the delivery of palliative and end of life care; and promote health behaviors that may reduce the risk of second malignancies. Instrument development, observational studies, and innovative approaches for these populations are needed before research can proceed.

3. Promoting a Healthy Diet and Physical Activity:

Nutrition and physical activity as keys to an energy balance strategy play an important role in the prevention of the initiation, promotion, and progression of cancer. Only a small proportion of the U.S. population adheres to recommended guidelines for diet or participates in regular physical activity, and obesity is now recognized as a national disease. Refinement of current theoretical mechanisms of behavior change as well as a focus on developing new models is needed to examine and explain the determinants of changes in unhealthy behaviors. How individuals and groups maintain healthy behaviors is also of interest. Relatively little research has been published on key theoretical measures of constructs, such as self-efficacy or perceived barriers when applied to fruit and vegetable consumption. Little is known about measures appropriate for minority, low-literacy, and/or high-risk populations. Innovative intervention designs must be assessed for feasibility and cultural competence before they can be targeted to populations at high risk for cancer.

4. Prevention and Control of Tobacco Use and Environmental Tobacco Smoke (ETS) Exposure among Children, Youth, and Adults:

In recent years, significant strides have been made in reducing tobacco use and ETS exposure in the United States; however, we must accelerate progress by all Americans to reach the goals set by Healthy People 2010. In addition, progress has been uneven and some population groups remain at continued high risk, such as: people living in poverty and/or with low educational attainment; members of some racial/ethnic groups; blue-collar and service workers; individuals with co-existing mental health or drug dependencies; youth with multiple risk or problem behaviors; incarcerated individuals; and others. There remains a continuing need for research aimed at developing innovative prevention and control strategies with broad public health application. Research is also needed to identify and test innovative programs and policies to reduce tobacco use and ETS exposure, especially among high risk populations. There is a need to better understand the factors -- genetic, behavioral, psychosocial, cultural, and environmental -- that impact upon tobacco use and ETS exposure among both youth and adults. Research is also needed to identify and test innovative behavioral and pharmacological treatments (alone or in combination) to improve upon current levels of treatment efficacy. As nations around the world confront the epidemic of tobacco use, research to understand the efficacy and effectiveness of prevention and control strategies used internationally will help inform work in the U.S.

5. Researching Biological Mechanisms of Psychosocial Effects on Disease:

The NCI supports biobehavioral studies of the cancer control continuum. We encourage the exploration of biological mechanisms and signaling pathways that might mediate observed associations between psychosocial/behavioral factors (e.g., life stress, psychological processes, and health behaviors) and cancer initiation and progression. Such research might consider the influence of stressors and concomitant central nervous system-mediated responses on tumor- and treatment-related processes and the microenvironment, viral oncogenesis, and tumor immunology. This NCI program supports human studies and animal studies with high translational potential. Research supported through this mechanism should strive to expand our knowledge of the dynamic bidirectional relationship between cancer risk/susceptibility, incidence, progression, and the host, as mediated by biobehavioral mechanisms.

6. Issues Involved in Cancer Screening Behaviors:

Social and behavioral research, in both community and clinical practice, is encouraged in order to develop effective strategies for: a) promoting cancer screening methods that are known to reduce cancer morbidity and mortality; and b) facilitating decision making when the evidence of a mortality benefit from early detection is uncertain. Particular areas of interest include the need to identify effective and appropriate messages related to cancer screening among sub-groups (e.g., ethnic, gender and income), and the development of methods for improving patient/provider communication and decision making about screening particularly in the context of new and changing screening technology and guidelines. Also of interest is research to incorporate risk assessment and communication, genetic susceptibility, genetic risk information, and biological risk into screening programs. Assessing the delivery, utilization, and evaluation of short-term outcomes of colorectal cancer screening in primary care practice is also of interest.

Crosscutting Themes

Although individual branches within the Behavioral Research Program or the Office of Cancer Survivorship concentrate on tobacco cessation, health promotion, communication, biobehavioral mechanisms, and/or survivor issues, the following are relevant to all areas of behavioral and social research, and, therefore, are strongly encouraged as cross-cutting themes to be considered in applications prepared in response to this FOA.

1. Consideration of Ethnicity, Social Class, and Culture:

The development and testing of interventions with valid and reliable measurement tools that are practical and culturally competent are needed. Since little is known about the relative importance of sociocultural, economic, educational, literacy, and other behavioral factors to the differential burden of cancer in the U.S., special efforts are required to identify and reduce the risk, incidence, and mortality of cancer among population subgroups and underserved populations. These populations and groups/subgroups include: racial/ethnic minorities, rural, elderly, immigrant, and under-insured populations. In addition, we need to examine both system-wide as well as individual and group barriers to screening, medical treatment, adherence, and end-of-life care. The medical system and its cultural components as they impact on cancer disparities are also of interest.

2. Methods and Measurement:

Innovative methods as well as measurement and analysis techniques are a critical need within many domains of the behavioral and social sciences. We encourage research that focuses on understanding the theoretical mechanisms of behavior change, and on developing new models as well as refining current theories. We need to develop instrumentation methods and measurement that can be used to evaluate the impact of environmental and policy interventions and develop sociocultural/ ecological perspectives as the context for behavior change. Qualitative research methods based on sound theoretical models have potential value for understanding the complexity of health behaviors.

3. Levels of Analysis:

We encourage increased attention to group as well as individual behaviors. Study designs, including intervention approaches and statistical analyses, must extend from individual analysis to an emphasis on multiple population levels (e.g., communities, clinics, neighborhoods, etc.). Understanding the success or failure of interventions will also depend on the ability to study the mechanisms of intervention impact and dissemination.

4. Research Settings:

Behavioral and social research initiatives may focus on any or all phases of the cancer control continuum, from prevention, detection, diagnosis, and treatment, through survivorship and end-of-life issues. Research activities may take place in a variety of settings as noted above. Exploratory studies of novel approaches targeted at specific research settings are encouraged.


Research funded through this R21 mechanism is expected to increase scientific knowledge about cancer health behaviors and health care practitioners' behaviors in a number of areas. These behaviors include: tobacco cessation, sun exposure, cancer screening behaviors, diet, weight, and physical activity factors relevant to cancer risk reduction. In addition, we are interested in areas that involve: cancer treatment, communication, informatics, and technologies which enhance coordination between health care practitioners and patients and informal care givers, cancer survivorship issues, socio-cultural factors in health behaviors and in health care practitioner behaviors, and basic bio-behavioral factors. We also encourage inquiries into areas such as risk communication, health literacy inequality, and the impact of mass media on cancer-related risk behaviors.

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 Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, which was published in the NIH Guide on May 7, 2003.

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.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 2-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined 2-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation.
See NOT-OD-05-004, which was published in the NIH Guide.

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:

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.

The most current Grants Policy Statement can be found at

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

Registration and Instructions for Submission via

To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this FOA, link to and follow the directions provided on that Web site.

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

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 Started.

2) Organizational/Institutional Registration in the eRA Commons

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

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 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

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:

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 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 R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

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

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

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

Date: May 2, 2006
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s):
AIDS Application Submission Date(s):
Peer Review Date(s):
Council Review Date(s):
Earliest Anticipated Start Date(s):

3.A.1. Letter of Intent

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

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via and follow steps 1-4. Note: Applications must only be submitted electronically.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by 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, 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.

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 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.

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 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 are to be followed, with the following requirements for R21 applications:

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 Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications 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 ( will evaluate applications for scientific and technical merit.

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

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:

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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 SF 24 (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 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 Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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:

Sabra F. Woolley, Ph.D.
Health Promotion Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 4078, MSC 7335
Bethesda, MD 20892-7335 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 435-4589
Fax: (301) 480-2087

2. Peer Review Contacts:

Not applicable.

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) 496-7800
Fax: (301) 496-8601

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 (

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,

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 (

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 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 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 (; a complete copy of the updated Guidelines is available at 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 (

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( 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 and view the Policy or other Resources and Tools including the Authors' Manual (

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 ( 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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at 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

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:

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