Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) Office of Behavioral and Social Sciences Research (OBSSR)
Funding Opportunity Title	School Nutrition and Physical Activity Policies, Obesogenic Behaviors, and Weight Outcomes (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	Reissue of PA-10-053
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-13-098
Companion Funding Opportunity	PA-13-100, R01 Research Project Grant PA-13-099, R03 Small Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865, 93.399, 93.837
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) is issued by the National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the Office of Behavioral and Social Sciences Research (OBSSR). The FOA encourages Research Project Grant (R21) applications that propose to: (1) foster multidisciplinary research that will evaluate how policies (federal, state and school district levels) can influence school physical activity and nutrition environments, youths obesogenic behaviors (e.g., nutrition and physical activity behaviors), and weight outcomes; (2) understand how schools are implementing these policies and examine multi-level influences on adoption and implementation at various levels (e.g., federal, state, school district, and school); and (3) understand the synergistic or counteractive effect of school nutrition and physical activity polices on the home and community environment and body weight.

Posted Date	February 1, 2013
Open Date (Earliest Submission Date)	May 16, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard AIDS 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	Standard dates apply
Expiration Date	May 8, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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) is issued by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the Office of Behavioral and Social Sciences Research (OBSSR). The FOA encourages exploratory/developmental research grant (R21) applications that propose to: (1) foster multidisciplinary research that will evaluate how policies (federal, state and school district levels) can influence school physical activity and nutrition environments, youths obesogenic behaviors (e.g., nutrition and physical activity behaviors), and weight outcomes; (2) understand how schools are implementing these policies and examine multi-level influences on adoption and implementation at various levels (e.g. federal, state, school district, and school); and (3) understand the synergistic or counteractive effect of school nutrition and physical activity polices on the home and community environment and body weight. The Social Ecological Framework is one of several frameworks that can be used to examine the interrelations among polices aimed at the school and home environment, individual diet and physical activity behaviors and weight outcomes.

This FOA will utilize the Exploratory/Developmental (R21) Grant mechanism, and runs in parallel with two other FOAs of identical scientific scope, PA-13-100 and PA-13-099 that encourage applications under the NIH Research Project (R01) and NIH Small Grant (R03) grant mechanisms.

The R21 grant mechanism is used to support the following types of research:

• Exploratory, novel studies that break new ground or extend previous discoveries toward new directions or applications.
• High risk high reward studies that may lead to a breakthrough in a particular area, or result in novel techniques, agents, methodologies, models or applications that will impact biomedical, behavioral, or clinical research.

Projects should be distinct from those supported through the traditional R01 mechanism.

Childhood Obesity as a Public Health Concern. Childhood obesity is a serious public health problem with both imminent and long-term detrimental health effects. Data collected from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) indicate that 26.7% of youth aged 2-5 years, 32.6% of youth aged 6-11 years, and 33.6% of youth aged 12-19 years are either overweight or obese, or have a body mass index (BMI) equal to above their age- and gender-adjusted 85th percentile. Childhood obesity can have serious consequences such as hypertension, dyslipidemia, insulin resistance, type 2 diabetes, fatty liver disease, obstructive sleep apnea and psychosocial difficulties. Obese youth are also at increased risk during their life course for developing many chronic diseases, including cardiovascular disease, type 2 diabetes, and cancer at multiple sites.

Childhood-prevention Strategies in the School Setting. The school setting (elementary, middle, high school) provides an ideal context for childhood obesity-prevention strategies. American youth consume approximately one-third of their energy intake while at school, and are expected to expend about half of their energy at school. Despite numerous recommendations for environmental- and policy-level strategies to combat obesity, the focus of most obesity- prevention strategies in the school context has been at the individual level. To date, such individually based intervention strategies have resulted in relatively modest changes in behavior. Given the high cost of such interventions, they have limited opportunities to significantly impact obesity at the population level. School policy strategies are increasingly being proposed for addressing the childhood obesity epidemic; however, there is a desperate need to build the scientific knowledge base to inform policy development in this rapidly emerging field.

Definitions of Terminology: Policy and School . For purposes of this FOA, policy is broadly defined to include both formal public policies as well as informal or implementation-type policies that may relate to student s obesogenic behaviors. Of particular interest are policies that relate to schools and neighborhoods surrounding the schools that might affect, directly or indirectly, student behaviors. Formal policies include, but are not limited to, statutes, codes, and ordinances, administrative rules and regulations, executive orders, judicial decrees, and policies issued by school districts and other local governmental agencies (e.g., planning and zoning commissions, departments of public works/transportation). Informal policies may include administrative guidelines, procedures, management bulletins, and guidance documents issued by governmental agencies, which often provide detailed interpretations of the formal policies as well as specific approaches as to how the formal policy is being implemented. Finally, school is defined as an entity that includes, but is not limited to, a public or private school (elementary, middle, high school), a child-care center, or an after-school program whereby federally-funded meals (including breakfast, lunch, dinner, and snacks) are served.

Policies that Govern the School Environment. Many policies that govern the school environment have been enacted at the state, school district, or school levels. Currently, states, school districts, and individual schools have enacted or considered enacting policies which may affect: (a) availability of competitive foods (foods offered at school other than meals served through USDA’s school meal programs); (b) use of food marketing strategies; (c) amount of time and place students eat lunch and breakfast; (d) use of food as a reward in the classroom; (e) types of food made available as part of fundraising activities and for social and classroom events; (f) qualifications of the food service director or physical education teacher; (g) standards and time requirements for nutrition and physical education; and (h) assessment of fitness or body mass index at school.

Prevailing Public Health Policies on Childhood Obesity. Several IOM reports provide expert guidance for the ongoing development of policy-based strategies geared towards modifying the school nutrition environment. Examples include Accelerating Progress in Obesity Prevention (http://www.iom.edu/Reports/2012/Accelerating-Progress-in-Obesity-Prevention.aspx); Food Marketing to Children and Youth; Nutrition Standards for Foods in Schools; Local Government Actions to Prevent Childhood Obesity; and School Meals: Building Blocks for Healthy Children (http://www.iom.edu/en/Reports.aspx). In the most recent IOM report, one of the main recommendations is that schools are made a national focal point for obesity prevention. Guidance for physical education policy and practices has been provided by the National Association for Sports and Physical Education (NASPE [http://www.aahperd.org/naspe/]). NASPE is a non-profit organization that provides standards for physical education and physical activity in schools. While policy-based approaches to combat obesity in schools exist, knowledge is lacking in key areas concerning the optimal policies, key implementation strategies for such policies, and the impact of these policies on a number of outcomes (e.g., behaviors, weight outcomes, and school achievement and revenues).

Support exists for using policy-based approaches to decrease the prevalence and impact of obesogenic behaviors in schools. The availability of competitive foods and marketing practices has been associated with poor nutrition. Participation in the National School Lunch Program, lengthening the school lunch period, nutrition education, and pricing strategies have been associated with healthier food choices and practices. With respect to physical activity, there is some evidence that increasing time spent in physical education (PE), modifying the PE curriculum, changing teacher qualifications (e.g., having a degree and specific training in physical education), and increasing recess time and/or access to physical activity equipment and games, are associated with increased physical activity and/or improved physical fitness. In sum, these studies provide limited initial empirical support for using policy-based strategies aimed at changing the school nutrition and physical activity environment. With the exception of marketing strategies, much of the evidence has been derived from cross-sectional studies. In addition, when attempting to examine the impact of policy strategies on behavioral outcomes, many of the studies have used overall behavior as their outcome, rather than focusing on school behaviors and differentiating them from behaviors occurring outside the school such as home and community environment.

Policies that Affect the Home and Community Environment. The home and community environment can complement or hinder the effectiveness of school-based intervention to prevent childhood obesity. Research suggests that healthy food at home, family rules, mealtime routines, parental encouragement, parental food intake, and child-feeding practices are associated with increased consumption of nutritious food. Conversely, low socioeconomic status, watching television during meal times, and negative feeding practices are associated with consuming unhealthy foods. Research also suggests that children who frequently watch television during dinnertime have higher BMIs. Furthermore, skipping breakfast and frequent fast food consumption at home was associated with risk of being overweight. The home environment is also associated with children’s physical activity levels and being overweight. One study showed that young children who had low family active-recreation time were more likely to be inactive during adolescence. Studies need to consider the possible synergistic or counteractive effect of the home and community environment on youths nutrition and physical activity behaviors and weight outcomes when examining the influence of school policies. It is possible that the independent effect of school, home and community environments are not noticeable, but there may be cumulative effects. Therefore, studies that consider the various levels of influences and the socio-cultural context on the school environment are imperative to elucidate when, with whom, and under what conditions, are school policies effective on youths obesogenic behaviors.

Policy Adoption and Implementation. Few studies to date have examined the policy adoption and implementation process. It is well established that enactment of a policy does not guarantee adoption or proper implementation. The organizational structure of schools is complex, and decisions that govern the school physical activity and nutrition environment are affected by multiple factors. Externally, schools have requirements and constraints imposed by federal and state agencies, and locally they respond to district requirements as well as accountability to taxpayers and parents concerns. There is a need to understand predictors of implementation while considering the complexity of influences on the school environment.

The specific research objectives of this FOA are to understand how school-related policies impact the school and home environment, promote positive nutrition and physical activity behaviors, and decrease childhood obesity. Other school outcomes, such as academic achievement and school revenues, may be included as covariates and are welcome as secondary outcomes. However, the study must primarily focus on youths obesogenic behaviors and/or weight outcomes or at understanding factors that influence the implementation process of physical activity and nutrition policies in the school setting. Applicants must have a tracking system to determine the impact of the policies on behaviors, to elucidate which policies have the greatest effect in changing behaviors. Finally, applications that focus on reducing health disparities as well as those focused on minority populations are particularly encouraged.

Specific research areas of interest include, but are not limited to, the following areas:

• What effect do school physical activity and nutrition policies, enacted at various levels, have on: youths obesogenic behaviors (physical activity and nutrition behaviors) inside and outside of school; youths weight; cardiovascular and other chronic disease risk, cancer, and school outcomes (e.g., academic achievements and school revenues)?
• Under which conditions (e.g. social climate), settings (e.g. public vs. private), and for whom (e.g., racial/ethnic and/or socioeconomic groups) are school policy strategies more likely to be effective in changing obesogenic behaviors, chronic disease risk factors or weight outcomes?
• What is the best way to measure the aggregate effect of multiple policies on the school environment as well as youths obesogenic behaviors and weight outcomes? Can single/individual policies have any noticeable effect on obesogenic behaviors, weight outcomes, cardiovascular and other chronic disease? Do multiple policies (enacted at various levels) have a cumulative, synergistic, or counteractive effect on youths obesogenic behaviors, weight outcomes, and chronic disease risk factors?
• Do home and community environments influence the efficacy or effectiveness of school- based policies aimed at improving the nutrition and physical activity environment of schools?
• To what extent do factors within (e.g., organizational climate, resources, infrastructure, competing priorities) and outside (e.g., federal, state, and school district, taxpayers and parents socio-cultural influences) the school environment influence the development, adoption and implementation of healthier policies?
• What factors impede or facilitate the adoption and implementation of policies within the school setting? Under which conditions (e.g. social climate) and settings (e.g. public vs. private) are schools more likely to implement physical activity and nutrition policies enacted at various levels or develop policies that create healthier school environments? How do these factors interact and what can be done to optimize their influence?
• How does the enactment of school policies at the state versus the district levels compare in their influence on the school environment? How much variability within policy provisions exists across state, school district, and school levels?
• To what extent can current school obesity-related policy classification systems (such as the NCI tracking system [http://dccps.nci.nih.gov/hprb/data_systems.html]) be used to track state and local (school district and school) policies as well as be used to evaluate implementation of policies in the school setting? What policies should be tracked and how does one validate the efficacy of such classification systems?
• What is the best way to test the effects of school policy changes on youth diet, physical activity and risk factors for cancer (e.g., obesity, hormones) and cardiovascular disease (e.g., blood pressure, blood lipids)?
• What is the best way to test the effects of obesity related school policy changes and their impact on home environment changes (e.g., reduction in TV and media usage) and health behaviors (e.g., diet, physical activity) of youth and families?

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (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.
Award Budget	Direct costs are limited to $275,000 over a two-year project period. No more than $200,000 may be requested in any single year.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed two 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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• 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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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 SF424 (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 registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 6 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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

Appendix

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-U.S.) 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 applications before 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 before the deadline 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 SF424 (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.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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 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.

Significance

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?

Investigator(s)

Are the PD(s)/PI(s), 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?

Innovation

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?

Approach

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 managed?

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?

Environment

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 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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

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.

Renewals

Not Applicable

Revisions

Not Applicable

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 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) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

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

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 Policy Statement.

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, SAM 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

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Layla Esposito, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6888
Email: [email protected]

Tanya Agurs-Collins, PhD, RD
National Cancer Institute (NCI)
Telephone: 240-276-6956
Email: [email protected]

Frank Perna, EdD, PhD
National Cancer Institute (NCI)
Telephone: 301- 451-9477
Email: [email protected]

Sonia Arteaga, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301- 435-6677
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Romy Reis
National Cancer Institute (NCI)
Telephone: 301-496-2834
Email: [email protected]

Tammi Simpson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301- 435-0150
Email: [email protected]

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.