PAR-09-003: Small Grants for Behavioral Research in Cancer Control (R03)

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.cancer.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-458.

Program Announcement (PA) Number: PAR-09-003

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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.

Catalog of Federal Domestic Assistance Number(s)
93.399, 93.361

Key Dates
Release/Posted Date: October 6, 2008
Opening Date: March 20, 2009 (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 Due Date(s): April 20, 2009; August 20, 2009; December 21, 2009; April 20, 2010; August 20, 2010; December 20, 2010; April 20, 2011; August 22, 2011; December 20, 2011
AIDS Application Due Date(s): Not applicable.
Peer Review Date(s): June/July 2009; October/November 2009; February/March 2010; June/July 2010; October/November 2010; February/March 2011; June/July 2011; October/November 2011; February/March 2012
Council Review Date(s): October 2009; January 2010; May 2010; October 2010; January 2011; May 2011; October 2011; January 2012; May 2012
Earliest Anticipated Start Date(s): December 2009; April 2010; July 2010; December 2010; April 2011; July 2011; December 2011; April 2012; July 2012
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 21, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This funding opportunity announcement (FOA), issued by the National Cancer Institute (NCI) and the National Institute of Nursing Research (NINR), at the National Institutes of Health (NIH), is intended to provide support for either new investigators in cancer-related behavioral research, or investigators who want to refocus their research interests toward behavioral research in cancer control. The program is designed to facilitate the growth of a nationwide cohort of scientists with research experience in behavioral cancer control and design of public health interventions. Preliminary data for the proposed projects are not required. Overarching goals are to: (1) encourage new investigators to enter the field of behavioral research in cancer controland initiate their long-term career development aimed at becoming independent investigators in the field, and (2) support research on transfer of behavioral science knowledge into cancer control practice.
Mechanism of Support. This FOA will utilize the NIH Small Grant (R03) mechanism.
Funds Available and Anticipated Number of Awards. 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 quality, duration, and costs of the applications received.
Budget and Project Period. Budgets for direct costs of up to $50,000 per year and a project duration of up to 2 years may be requested for a maximum of $100,000 direct costs over a 2 project period.
Research Plan Component Length: 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. See http://grants.nih.gov/grants/funding/funding_program.htm.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include a one page Introduction addressing the previous peer review critique (Summary Statement).
Renewals. The R03 is not renewable.
Application Materials. See Section IV.1 for application materials.
General Information. For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites:
SF424 (R&R) Application and Electronic Submission Information at http://grants.nih.gov/grants/funding/424/index.htm; and
General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Hearing Impaired. Telecommunications for the hearing impaired is available at: TTY 301-451-0088.

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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

This FOA is intended to provide support for investigators in cancer-related behavioral research, or investigators who want to refocus their research interests toward behavioral research in cancer control.

The program is designed to facilitate nationwide the growth of a cohort of scientists with research expertise in behavioral cancer control, including design and conduct of public health interventions. The award provides support for pilot or feasibility studies, development and testing of new methodologies, development and testing of new research technologies, secondary analyses of existing data, self-contained research projects, and innovative studies that provide bases for more extended research. The overarching goals are to encourage new investigatorsto enter the field of behavioral research in cancer controlwhile also facilitating their long-term career development asprincipal investigators within the field, and to support research on how to best transfer behavioral science knowledge into cancer control practice.

This FOA uses the R03 grant mechanism, which supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support small research projects that can be carried out in a short period of time with limited resources.

Background

One-half to two-thirds of cancer deaths can be linked to behavioral factors. In 1998, the Behavioral Research Program (BRP) was created withinthe Division of Cancer Control and Population Sciences (DCCPS). TheBRP provides resources and funding opportunities for cancer-relatedresearch in the social and behavioral sciences through its fivebranches: (1) Applied Cancer Screening; (2) Basic and BiobehavioralResearch; (3) Health Communications and Informatics; (4) Health Promotion; and (5) Tobacco Control. This researchprogram reflects NCI’s recognition of the effect of health behaviors on cancer risks, andits strong commitment to advance social, behavioral,and population sciences as integral to the conduct of appliedand interdisciplinary research in cancer prevention and control. This led BRP to develop the “Small Grants Program” (SGP) for BehavioralResearch in Cancer Control. For additional information go to http://cancercontrol.cancer.gov/smallgrants/

For NINR-supported applications, eligible applicants must be new investigators, as defined by the NIH (see page I-26, http://grants1.nih.gov/grants/funding/phs398/phs398.pdf). For the purposes of review and funding, applicants are considered new investigators if they have not previously served as a Principal Investigator (PI) on any DHHS-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain mentored research career development awards for persons at the beginning of their research career (K01, K08, K22, K23, K25, K99/R00). Current or past recipients of Independent Scientist and other non-mentored career awards (e.g., K02, K05, K24, and K26) are not considered new investigators. For NCI-supported applications, in addition to new investigators, eligible applicants can include independent/experienced investigators who want to refocus their research interests to behavioral research in cancer, and who have not previously been PIs on an NCI-supported cancer control research grant (R03, R01, U01, P01, and R21).

Specific Research Objectives

This FOA is intended to support new investigators whose interests focus on behavioralresearch aimed at helping people control behaviors that increase cancerrisk.

Areas of cancer control and behavioral science research activities appropriate for this funding opportunity include, but are not limited to, the following examples:

A. Cancer Screening

Theory and methods development, effectiveness trials and related social, behavioral and health services research to promote the use of effective cancer screening and detection tests, follow-up of abnormal findings and unscreened populations; and
Strategies for informed decision making regarding all cancer-screening technologies in both community and clinical practice.

For additional information, go to http://dccps.nci.nih.gov/acsrb/priorities.html.

B. Basic and Biobehavioral Research

Studies that examine mechanisms, principles, and theoretical underpinnings of health-related behavior change across life course, different racial and ethnic groups, and socioeconomic strata;
Research in social, cognitive, and psychological processes (e.g., social comparison, mechanisms underlying neurocognitive changes associated with cancer treatment, emotion and motivation);
Studies of biological mechanisms of psychosocial or behavioral processes related to cancer progression;
Medical decision making (e.g., role of numeracy in medical decision making, elucidating decision processes involved in maintenance of healthy lifestyle behaviors);
Studies of genetic and environmental influences on health behaviors related to cancer diagnosis and control; and mediators and moderators of adaptation and coping;
Basic and applied research in health communication (e.g., message framing, use of heuristics, decision support);
Methodology and measurement in behavioral science research (e.g., psychophysiological assessment, measurement of stress and other psychological constructs);
Development and testing of models and theories of health behavior; psychosocial and behavioral consequences of cancer risk assessment (e.g., risk perception); and
Methodology-based studies to test theory-driven models and the use of innovative technology (e.g. real-time data analysis tools, sensors) to better understand health-risk behaviors.

For additional information, go to http://biobehavioral.cancer.gov.

C. Applied Research

Health monitoring, methods, and outcomes research;
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; and
Development of 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.

For additional information, go to http://appliedresearch.cancer.gov/.

D. Health Communication and Informatics Research

Studies that examine the use of new communication technologies, in cancer prevention, control, and care; and
Studies on communication campaigns, risk communication, information dissemination, social support, patient-centered communication and coordination of care.

Other examples may be found at http://dccps.nci.nih.gov/hcirb/about.html.

E. Health Disparities Research

Studies that identify and test strategies to address the behavioral, societal and environmental determinants of cancer health disparities;
Studies that develop and test promising interventions focusing on the reduction and elimination of cancer health disparities. These studies may use a variety of research approaches, including but not limited to initial stages of community-based participatory research, with the goal to reduce and eventually eliminate health disparities through partnerships jointly conducted by communities and researchers.

Additional information may be found at http://dccps.nci.nih.gov/od/healthdisp.html and http://crchd.cancer.gov/.

F. Health Promotion Research

Studies to change current behaviors and/or bring about new behaviors, such as those that improve diet, increase physical activity, achieve optimal energy balance as it relates to obesity prevention (both adult and child);
Studies that decrease virus exposure, skin cancer prevention (e.g. UV exposure, sun safety, indoor tanning), and improve psychosocial risk factors relevant to healthy behaviors and reducing incidence, morbidity, or mortality from cancer, are appropriate;
Novel research that integrates genes, eating behaviors or preferences and physical activity behaviors as it relates to obesity risk are encouraged;
Cancer prevention research to change and maintain the health behaviors listed above, include, but is not limited to, pilot studies, efficacy studies, and effectiveness studies that examine the individual at risk for cancer across the lifespan, community (includes healthcare providers), environmental, and/or policy factors that may affect the initiation or maintenance of cancer-related health behaviors, or studies affecting the translation of recommended health promotion guidelines into healthcare provider practice; and
Methodology studies to test theory-driven models and the use of innovative technology (e.g. real-time data methodology, sensors) to better understand the health behaviors listed above are also of interest.

Other examples may be found at http://healthpromotionresearch.cancer.gov

G. Cancer Survivorship and Bereavement

Studies that examine the adverse and/or positive effects of cancer diagnosis and treatment;
Studies that aim to prevent or control negative outcomes, and/or enhance positive outcomes, such as resilience among cancer survivors and their families;
Studies that have the potential to improve the quality of life of cancer survivors, their families, and caregivers;
Pilot investigations focusing on the development, delivery, and/or evaluation of interventions that carry the potential to improve the quality of life of cancer survivors;
Survivorship studies that 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 (i.e., psychometric analysis or development of a quality of life measure) specific to cancer survivors, their families, and caregivers;
Analyses of the economic cost of cancer survivorship;
Secondary data analysis of national data bases that elucidate survivorship needs and behaviors directed toward addressing treatment side effects, and work/employment issues; and
Studies that examine health promotion of cancer survivors, their families, and caregivers, such as tobacco and alcohol control, exercise promotion, and dietary interventions.

Other examples may be found at http://survivorship.cancer.gov.

H. Surveillance Research

Studies related to evaluating patterns and trends in cancer incidence, morbidity, mortality, and survival;
Innovative approaches that address surveillance using newly available data, linkage between existing data systems to create enriched databases for cancer surveillance;
Application of current statistical and economic methods to, for instance, ecologic studies of the cancer burden among various population groups (categorized according to geographic, socioeconomic, and/or systems-level factors);
Exploration of the links between population-based data on cancer and data on risk factors or health-related behaviors; linkage may be done by geographic area or by spatial proximity within a geographic information system;
Research to develop statistical or geospatial methodologies/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; and
Research to develop general statistical methodology relevant to the analysis of population-based data in cancer research. The development of well-documented, well-tested, user-friendly software for innovative statistical methodology is encouraged.

For additional information see http://statfund.cancer.gov/ and http://surveillance.cancer.gov/.

I. Tobacco Control Research

Tobacco use etiology, prevention, and cessation studies, including pilot studies that test strategies for improving utilization of current technologies in high-risk individuals and populations; and
Studies assessing the effect of various policies on tobacco initiation and use, as well as secondary data analyses of existing datasets.

Additional examples may be found at http://tobaccocontrol.cancer.gov.

J. Secondary Data Analysis

Applicants may conduct secondary analyses relevant to behavioral aspects of cancer prevention and control using large, nationally representative data sets or smaller, regional, or locally based data sets. Many of these data sets contain items relevant to cancer prevention and have not been fully analyzed. There are three types of data sets that would qualify for funding:

1) Publicly available data sets:

the Health Information National Trends Survey (HINTS; http://hints.cancer.gov) conducted by the National Cancer Institute;
the National Health and Nutrition Examination Survey (NHANES; http://www.cdc.gov/nchs/nhanes.htm) conducted by the National Center for Health Statistics (NCHS);
the National Health Interview Survey (NHIS; http://www.cdc.gov/nchs/nhanes.htm) conducted by NCHS;
the Current Population Survey (CPS; http://www.census.gov/cps), conducted by the Bureau of Labor Statistics and the Census Bureau;
the Behavioral Risk Factor Surveillance System (BRFSS; http://www.cdc.gov/brfss), conducted by the Centers for Disease Control and Prevention and
the California Health Inventory Survey (CHIS; http://www.chis.ucla.edu), conducted by UCLA Center for Health Policy Research, the California Department of Health Services, and The Public Health Institute.

2) ‘Limited use’ datasets (that have requirements that the users must agree to before analyzing them):

the Surveillance Epidemiology and End Results survey (SEER; http://seer.cancer.gov/); and
the National Longitudinal Study of Adolescents Health (http://www.cpc.unc.edu/addhealth).

3) Non-public domain datasets including data collected under research grant funds, data sponsored by private entities (e.g., philanthropic foundations, motor vehicle administrations, or commercial businesses) or originally collected for purposes other than research (e.g., health care, criminal justice or insurance data).

K. Behavioral Genetics

Applications focused on how genetic, environment, and behavioral factors interact in human physiological processes and influence disease expression and/or health outcome; and
Studies that explore the relationship between genotypes, environmental, and behavioral factors, specifically as they relate to food preferences and physical activity; these studies should be hypothesis-driven and methodologically rigorous in terms of integrating genetics, environment, and behavioral factors to specifically address questions of gene-environment-behavior interactions.

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.

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

Section II. Award Information

1. Mechanism(s) of Support

This FOA will use the NIH R03 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement.

Renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.

For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.

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 receipt of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this FOA may not exceed 2 years. A budget with a maximum of $100,000 in direct costs over the entire project period, may be requested. The direct costs in any one year must not exceed $50,000. Commensurate Facilities and Administrative (F&A) costs are allowed.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education;
Private Institutions of Higher Education;
Hispanic-serving Institutions;
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education);
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education);
Small Businesses;
For-Profit Organizations (Other than Small Businesses);
State Governments;
U.S. Territories or Possessions;
Regional Organizations; and
Eligible Agencies of the Federal Government.
Eligible Agencies of Local Governments

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

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills, and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application, but such application must include a one page Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may not submit a renewal application.

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

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or 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/applicants/get_registered.jsp) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

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

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

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 one to two 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
Email: support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.”
Direct questions regarding the Commons registration to:

eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours: M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email: commons@od.nih.gov

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(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
This registration/affiliation must be done by the AOR/SO or his/her 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 four 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 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

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.

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 “Frequently Asked Questions – Application Guide, 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 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 20, 2009 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
Application Due Date(s): April 20, 2009; August 20, 2009; December 21, 2009; April 20, 2010; August 20, 2010; December 20, 2010; April 20, 2011; August 22, 2011; December 20, 2011
AIDS Application Due Date(s): Not applicable.
Peer Review Date(s): June/July 2009; October/November 2009; February/March 2010; June/July 2010; October/November 2010; February/March 2011; June/July 2011; October/November 2011; February/March 2012
Council Review Date(s): October 2009; January 2010; May 2010; October 2010; January 2011; May 2011; October 2011; January 2012; May 2012
Earliest Anticipated Start Date(s): December 2009; April 2010; July 2010; December 2010; April 2011; July 2011; December 2011; April 2012; July 2012
Expiration Date: December 21, 2011

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due 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 weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
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 it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to “Reject” the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The “Reject” feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
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.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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 that such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

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. This information must be included at the end of Background & Significance section in the Research Plan, and should not exceed one page. The mentor’s proposed percent effort commitment to the mentoring plan should also be stated. This percent effort information must be included in the Personnel Justification section. Letters of Support are to be included in the Research Plan (see http://www.grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf).

In the budget requests, applicants should plan for the 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.

PD/PI Credential (e.g., Agency Login)

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 “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.

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

R03 applications will use the modular as well as the non-modular budget formats and “Just-in-Time” information concepts, with direct costs requested in up to two $25,000 modules, or $50,000 per year, for up to 2 years (i.e., a maximum of $100,000 over 2 years in four modules of $25,000 each).
Items 2-5 of the PHS398 Research Plan component of the R03 application may not exceed 10 pages, including tables, graphs, figures, diagrams, and charts.
Introduction (required for a resubmission application) is limited to one page.
Preliminary data are not required but may be included if available.
R03 Appendix materials may include ONLY pre-printed questionnaires or surveys. No publications or figures are allowed in the Appendix.
Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan Component. An application that does not observe these limitations may be delayed in the review process.

Resource Sharing Plan(s)

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

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

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

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

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 on the basis of established PHS referral guidelines to the ICs for funding consideration.

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

As part of the 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 an appropriate 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 and technical merit of the proposed project as determined by scientific peer review;
Availability of funds; and
Relevance of the proposed project to program priorities.

The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the Research Plan component is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing 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 from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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 comments, 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, and weighted 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 meritorious 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 be considered in the determination of scientific merit and the rating:

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See Item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See Item 7 of the Research Plan component of the SF424 (R&R).

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

2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

Data Sharing Plan. [http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm]
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

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/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 email 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.

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Veronica Chollette, R.N., M.S.
Program Director
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: vc24a@nih.gov
http://cancercontrol.cancer.gov/smallgrants/

Kathleen F. Jett, Ph.D, RN, GNP-BC
Program Director: Oncology, HIV/AIDS
National Institute of Nursing Research (NINR)
6701 Democracy Boulevard, Room 710, MSC 4870
One Democracy Plaza
Bethesda, MD 20892-4870 (for U.S. Postal Service express or regular mail)
Telephone: 301-594-2154
Fax: 301-480-8260
E-mail: jettk@mail.nih.gov
http://www.ninr.nih.gov/ResearchAndFunding/DEA/OEP/AreasofscienceFile.htm

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Suite 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: wolfreyc@mail.nih.gov

Kelli Oster
Office of Grants and Contracts Management
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870 (courier use 20817)
Telephone: (301) 594-2177
Fax: (301) 451-5651
E-mail: osterk@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); 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).

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

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS Office for Civil Rights (OCR).

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 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 PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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