National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Funding Opportunity Title
Healthy Habits: Timing for Developing Sustainable Healthy Behaviors in Children and Adolescents (R21)
R21 Exploratory/Developmental Research Grant Award
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.361, 93.837, 93.865, 93.213
This Funding Opportunity Announcement (FOA), issued by the National Institute of Nursing Research (NINR) with participation from the National Heart, Lung, and Blood Institute (NHLBI), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM), and the Office of Behavioral and Social Sciences Research (OBSSR), is to encourage Exploratory/Developmental Research Grant Award (R21) applications that employ innovative research to identify mechanisms of influence and/or promote positive sustainable health behavior(s) in children and youth (birth to age 18). Positive health behaviors may include: developing healthy sleep patterns, developing effective self-regulation strategies, adaptive decision-making in risk situations, practicing proper dental hygiene, eating a balanced and nutritious diet, engaging in age-appropriate physical activity and/or participating in healthy relationships. Applications to promote positive health behavior(s) should target social and cultural factors, including, but not limited to: schools, families, communities, population, food industry, age-appropriate learning tools and games, social media, social networking, technology and mass media. Topics to be addressed in this announcement include: effective, sustainable processes for influencing young people to make healthy behavior choices; identification of the appropriate stage of influence for learning sustainable lifelong health behaviors; the role of technology and new media in promoting healthy behavior; identification of factors that support healthy behavior development in vulnerable populations, identification of barriers to healthy behaviors; and, identification of mechanisms and mediators that are common to the development of a range of habitual health behaviors. Given the many factors involved in developing sustainable health behaviors, applications from multidisciplinary teams are strongly encouraged. The ultimate goal of this FOA is to promote research that identifies and enhances processes that promote sustainable positive behavior or changes social and cultural norms that influence health and future health behaviors.
September 1, 2011
Open Date (Earliest Submission Date)
September 16, 2011
Letter of Intent Due Date
Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review
Standard dates apply
Advisory Council Review
Standard dates apply
Earliest Start Date(s)
Standard dates apply
Now April 19, 2014, reissued as PA-14-176 (Originally, September 8, 2014)
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA), issued by the National Institute of Nursing Research with participation from National Heart, Lung, and Blood Institute (NHLBI), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM), and the Office of Behavioral and Social Sciences Research (OBSSR), is intended to stimulate Exploratory/Developmental Research Grant Award (R21) applications that employs innovative research to identify mechanisms of influence and/or promote positive sustainable health behavior(s) in children and youth (birth to age 18). Positive health behaviors may include: developing healthy sleep patterns, developing effective self-regulation strategies, employing effective decision-making in risk situations, practicing proper dental hygiene, eating a balanced and nutritious diet, engaging in age-appropriate physical activity and/or participating in healthy relationships. Applications to promote positive health behavior(s) should target social and cultural factors, including, but not limited to: schools, families, communities, population, food industry, age-appropriate learning tools and games, social media, social networking, technology and mass media. Topics to be addressed in this announcement include: effective, sustainable processes for influencing young people to make healthy behavior choices; identification of the appropriate stage of influence for learning sustainable lifelong health behaviors; the role of technology in promoting healthy behavior; identifying factors that support healthy behavior development in vulnerable populations; and, identification of mechanisms that are common to the development of a range of sustainable health behaviors. Given the many factors involved in developing sustainable health behaviors, applications from multidisciplinary teams are strongly encouraged. Applications should explicitly address the degree to which behaviors are sustained over time. Research that identifies and enhances processes, including social and cultural norms, that promote positive behavior in children and youth that is sustainable throughout life is the ultimate goal of this FOA.
One goal of NIH is to prevent disease, and considerable data support the notion that lifestyle changes can have a tremendous impact on the prevalence of many diseases, including, but not limited to cardiovascular disease, diabetes, cancer, substance abuse, and sexually transmitted diseases. Several Institutes and Centers of the NIH have invested in research to promote and sustain healthy behaviors; however, the development of healthy behaviors that sustain a healthy lifestyle during childhood and adolescence has been under studied. Behaviors and decision-making processes learned and habituated at a young age are likely to be more sustainable over time, and thus may have greater impact than attempting to change the behavior of adults. Questions that need to be addressed include: How do we influence children and youth to make healthy behavior choices? When are health-promoting behaviors learned and internalized as lifelong health practices? What are the most effective age-appropriate mechanisms for developing sustainable health behavior throughout the lifespan? When are the optimal developmental periods for developing sustainable health behaviors? How do children and youth learn to make age-appropriate decisions about health behaviors? Does the development of age-appropriate decisions about health behavior differ by gender or for children with disabilities? What biobehavioral factors influence youth to cease healthy behaviors (physical activity, drug free) and initiate less healthy behaviors (decreased physical activity, excessive use of media, substance use)? What are the ages of influence for learning different sustainable lifelong health behaviors? Are there common core mechanisms that underlie the development of multiple health behaviors?
The dramatic increase of obesity in America’s youth and the continued use of tobacco and drugs have proven very difficult to reverse, while decades of research documents the challenge of initiating and maintaining behavior change. Taken together these data suggest the need to instill health promotion at developmentally appropriate periods instead of remedying aberrant behavior later in life. For example, methods such as social media have shown enduring effects for changing norms in consumer behavior at the population level. Is it possible to harness these methods to enhance learning of positive health behaviors, rather than to promote products?
The funding opportunity announcement encourages applications targeting basic or applied research, depending on the state of the science. Where there is evidence of the value of an approach to developing healthy sustainable behavior, but there are key questions that are yet to be answered, then an intervention of limited scale would be appropriate. Before the large, rigorous and well-designed studies that are required to address these questions can be implemented, important early-phase research and development must be completed. In order to elucidate the optimal research strategy, a number of steps are necessary, such as characterization of the intervention, determination of suitable outcome measures, and identification of the optimum population and randomization approach. Applicants must provide a clear and compelling rationale for pursuing study and development of the intervention, as well as for other critical aspects of the research design (e.g., dose or schedule, choice of endpoints of interest, etc). Applications that leverage existing research infrastructures, for example through follow-ups or use of relevant existing data sets or ancillary studies to existing large-scale studies, are also encouraged.
Topics to be addressed in this announcement include, but are not limited to:
The evolution and vitality of the biomedical 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 R21 mechanism, the NIH 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.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
The combined budget for direct costs for the two (2) year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
Award Project Period
The maximum project period is two (2) years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program 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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
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 only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. 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.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data and
safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
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. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Linda S. Weglicki, PhD, RN, MSN
National Institute of Nursing Research (NINR)
S. Sonia Arteaga, PhD
Division of Cardiovascular Sciences; National Heart Lung and Blood Institute (NHLBI)
Layla Esposito, Ph.D.
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301 435-6888
Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Alternative Medicine (NCCAM)
Wendy J. Nilsen, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Phone: (301) 496-0979
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Mr. Ron Wertz
National Institute of Nursing Research (NINR)
Phone: (301) 594-2870
Kimberly Stanton, Grants Management Specialist
National Heart, Lung and Blood Institute (NHLBI)
Bryan S. Clark, Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Natasha Loveless, Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
George A. Tucker, M.B.A., C.G.M.S., Director, Office of
Division of Extramural Activities, National Center for Complementary and Alternative Medicine (NCCAM)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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.
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