Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Testing Interventions for Health-Enhancing Physical Activity (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-14-315

Companion Funding Opportunity

PAR-14-321, R21/R33 Phased Innovation Award

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865; 93.866; 93.399; 93.273; 93.313, 93.279 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to fund highly innovative and promising research that tests multi-level intervention programs of 1 to 2 years in length that are designed to increase health-enhancing physical activity: 1) in persons or groups that can benefit from such activity; and 2) that could be made scalable and sustainable for broad use across the nation.  This FOA provides support for up to 5 years for research planning, intervention delivery, and follow-up activities.  

Key Dates
Posted Date

August 13, 2014

Open Date (Earliest Submission Date)

October 1, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

New applications: October 31, 2014; June 5, 2015; February 5, 2015; October 5, 2016; June 5, 2017, by 5:00 PM local time of applicant organization.

Resubmission applications: November 5, 2014; July 5, 2015; March 5, 2015; November 5, 2016; July 5, 2017, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

January 7, 2015, September 7, 2015, May 7, 2016, January 7, 2015, September 7, 2017 , by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

September 8, 2017

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.


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Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This FOA encourages innovative research to improve our understanding of how to increase and maintain health-enhancing physical activity to make meaningful and lasting change, with an emphasis on multi-level interventions that have the potential to be scalable, implementable, and sustained in real-world settings. Interventions to be tested should seek to increase participants’ progression toward achieving the 2008 Physical Activity Guidelines for Americans as appropriate to the participants’ health, abilities, and conditions. The intent of this announcement is to address physical activity as it relates to conditions other than obesity or energy balance, such as cardiorespiratory fitness, reduced rates of cancer, bone health, mental health, or substance abuse. The interventions to be tested can include diverse strategies delivered at multiple levels to promote health-enhancing physical activity as a primary outcome. This FOA also seeks studies that address a wide range of population groups across the lifespan (e.g., racial and ethnic minorities, children, elderly populations, persons with medical conditions, and persons with disabilities). Investigators are encouraged to build on prior research to refine interventions and to make use of innovative partnerships within and across sectors (e.g., partnerships with community organizations, faith-based organizations, businesses, government, and/or healthcare providers) as needed to implement the proposed multi-level intervention. For investigators that need sufficient time to develop meaningful collaborations, pilot, or refine interventions previously used in different settings or populations, please see the companion Exploratory/Developmental Phased Innovation (R21/R33) PAR-14-321.

Background

Physical activity is an important health behavior that is associated with numerous health conditions and outcomes. Findings delineated in the evidence report for the 2008 Physical Activity Guidelines for Americans as well as numerous other publications, show that moderate-to-vigorous aerobic physical activity in adults is associated with many health benefits. Physical activity is defined as bodily movement that expends energy, but not all the positive health outcomes from physical activity are due to the expenditure of energy per se. For example, aerobic activity increases the contractility and stroke volume of the heart muscle, increases blood flow through the body’s vascular system, improves oxygen uptake in the lungs, and relaxes the peripheral vasculature. These changes improve the body’s cardiorespiratory fitness level and lower blood pressure, which help reduce cardiovascular events like heart attacks and strokes. Aerobic physical activity also increases uptake of blood glucose by the body’s cells through increases in insulin sensitivity, thus helping to control blood sugar levels in people with diabetes or pre-diabetes. Strength training and weight-bearing physical activity improves the contractility of peripheral muscles and preserves muscle mass during aging, improving the ability to function independently during the aging process.  In youth, studies have shown that physically active children and youth have higher levels of cardiorespiratory endurance and muscle strength, lower levels of body fat, more favorable cardiovascular and metabolic disease risk profiles, enhanced bone health, reduced symptoms of anxiety and depression, and improved academic performance.

Despite the well-recognized benefits of physical activity, the proportion of people in the United States that engages in a level of physical activity that can promote their health is far less than desired, with only one in five U.S. adults meeting the overall 2008 Physical Activity Guidelines for Americans.  Because of the myriad of health conditions that physical activity affects, it is important to assess the level of physical activity in various population groups and to determine what strategies might be useful for increasing the type of physical activity that could benefit those groups.

In December 2012, the NIH Office of Disease Prevention (ODP) held a trans-NIH workshop on research priorities for physical activity and disease prevention. The workshop focused on research to promote health-enhancing physical activity in the U.S. Discussions addressed the NIH’s interest in supporting innovative and promising research to improve physical activity interventions in diverse age and racial/ethnic populations; identifying barriers and facilitators to achieving national physical activity guidelines; and prioritizing the NIH physical activity research agenda. One of the main messages that emerged was the need for research that moves beyond individual and single-level interventions to incorporate action at two or more levels, such as families, organizations, and communities in addition to individuals (for more information, see multi-level intervention examples listed below). The 2008 Physical Activity Guidelines for Americans recommend that healthy adults engage in at least 150 minutes per week of moderate intensity aerobic activity, 75 minutes of vigorous aerobic activity, or an equivalent combination of moderate and vigorous activity, in addition to twice a week muscular strengthening exercises.  For youth, the Guidelines recommend an hour a day of moderate to vigorous aerobic activity. Recommendations for persons with various medical conditions are also included in the Guidelines.

The Guidelines’ recommendations are based on evidence showing that the level of activity is associated with improved health benefits and well-being. Studies also show that gradually increasing activity in persons who are inactive is safer than increasing activity rapidly and dramatically and is more likely to result in long-term adherence. In addition, health benefits may begin with less activity than the level recommended, with more activity leading to greater and additional benefits. So, increasing activity levels across the spectrum—from sedentary to meeting the guidelines and even higher—has the potential to improve the nation’s health.

Studies have been conducted to test various intervention strategies to help inactive people become more active.  In general, behavioral strategies – which include approaches like individualized goal setting, self-monitoring, problem solving around barriers to activity change, and positive reinforcement for achieving goals – are more effective.  Interventions that consider the context in which physical activity may happen (e.g., in families, social groups, worksites) also hold potential.  There is also evidence that living in an environment more conducive and supportive of physical activity, such as a more walkable community with interconnected streets and sidewalks, is associated with higher levels of physical activity. However, there has been little research examining interventions that target both individuals and their environments.  Despite the paucity of research in this area, promising examples include a multilevel ecological approach to promoting walking in communities and a socio-ecological approach to promoting physical activity and limiting sedentary behavior in adolescents.   

Research Objectives

This FOA seeks studies that test multi-level interventions to increase physical activity levels based on well-established theory and existing data. Interventions to be tested should have an expanded focus beyond the individual level, or beyond the environmental level, to include two or more levels, such as individuals, families, social groups, institutional/organizational environments, worksite, healthcare systems, or community environments. Investigators are encouraged to incorporate both individual and environmental interventions that take into account motivational, cognitive and emotional components along with environments that facilitate and sustain change.  Multi-level interventions are thought to hold promise in enabling individuals to successfully change and maintain their physical activity-related health behaviors.  Investigators may propose other levels, but whatever levels are selected should be well-justified.

Interventions tested in more “real-world” settings that have the potential to be scalable, packaged for broad use, or informative for policy are encouraged. Packaging for broad use applies to interventions that have developed and tested: toolkits that provide implementation guidance, procedures and strategies, including recruitment tools, intervention design, recruitment of partners; analytical tools; appropriate measures of physical activity for the intervention and diverse population groups and settings; and supporting information so that others can replicate the study and potentially implement the program.

Given the relatively large cost in mounting community interventions, an assessment on resources spent on intervention development and maintenance is desired.  Data on costs of implementing and sustaining the intervention is encouraged, but complete cost-effectiveness analyses are beyond the scope of this announcement.  Costs can include actual costs for intervention development, implementation and, to a lesser degree, maintenance.  An example is the packaging of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Diabetes Prevention Program lifestyle intervention program for use in YMCAs across the country. Another example is National Heart, Lung, and Blood Institute (NHLBI) studies that tested interventions delivered in health care settings that have potential implications to inform reimbursement policy.  Potential for incorporation into community programs and through policy change also can enhance the likelihood of sustainability.

Due to funding limitations on the duration (5 years) of a R01 at NIH, it is expected that investigators who have done preliminary developmental work, including pilot studies or work with different population groups or single level interventions, would be more successful in responding to this FOA.  Preliminary developmental work on physical activity interventions should include needs assessments in population groups of interest and pilot testing interventions for feasibility and tailoring. Prior work may also include utilizing systems science to develop new intervention models based on analyzing key upstream influences. The use of fractional factorial designed studies that have identified promising intervention components, or previous studies testing adaptive interventions that changed during the course of the study, are also encouraged where appropriate.   Further, prior work demonstrating effectiveness at one level (individual or environmental) could be combined with work at another level to create multi-level intervention programs.

Studies in any age group and special population, including populations at high risk for sedentary behavior, are appropriate for this announcement. Sustainability for the purpose of this announcement is defined as one to two years post-intervention.  For example, an intervention targeting a population at risk for developing osteoporosis may include bone strengthening exercises, or an intervention targeting children at risk for obesity or diabetes may include increased physical education time during school hours. Populations of interest include, but are not limited to: 

- Healthy but sedentary or inactive individuals

- Persons or groups at high risk for a particular disease or condition that can be improved by physical activity

- Persons with an existing disease or condition (e.g., cardiovascular disease, cancer, clinical depression, or diabetes) whose outcomes could be improved by physical activity

- Children and adults of diverse socioeconomic, ethnic, and racial groups with low activity levels

- Persons with physical, developmental, or intellectual disabilities who may need special approaches for activity promotion

- Inactive or sedentary elderly individuals or groups

- Minority and underserved populations at higher risk for conditions associated with inactivity

- Other groups, if justified by the investigator

Comparison of male and female populations or subjects on the desired outcome is highly desired. Of particular interest are research activities which increase the understanding of sex and gender differences and factors in health and disease, to support implementation of the NIH Strategic Plan for Women's Health Research, available at http://orwh.od.nih.gov/research/strategicplan/index.asp.

Settings for the interventions can include healthcare settings, worksites, households, schools, green space, parks and recreation centers, other community organizations and settings, or entire communities.  Because this FOA seeks multi-level interventions that have the potential to be scalable and sustainable, the use of multiple settings for intervention implementation or support may be considered. Illustrative examples of studies testing multi-level interventions with two or more levels can be found in existing systematic reviews.

To date, the available body of research includes numerous studies with methodological issues and systematic reviews from the Cochrane Collaboration and the Community Preventive Services Task Force have resulted in conflicting findings. Thus, investigators should propose the strongest study design that can evaluate the effects of the intervention program with high internal validity, taking into account external validity and generalizability. In general, this would be a randomized controlled trial (RCT) design. Most studies proposed in response to this announcement will probably need randomization at the group level (Group Randomized Trial, or GRT) to match the level of intervention and to minimize or prevent contamination of the comparison group.  In some cases, a randomized design may not be possible or feasible, or would raise ethical concerns that are difficult to address. In such instances, investigators could propose and justify alternative, high-quality study designs. Such designs include, but are not limited to, quasi-experimental designs such as multiple baseline or time series, regression discontinuity, pre-to-post intervention with external comparison, natural experiments, or others (

Given the strong evidence that physical activity is associated with many health benefits, the primary outcome being sought is a measure of physical activity and/or change in physical activity over the duration of the 1-2 year intervention period in the direction of achieving the health-enhancing physical activity goals for the targeted population or patient subgroup, as identified in the 2008 Physical Activity Guidelines for Americans.  Therefore, the intervention and any comparison/control group should use appropriate and well-justified physical activity measures to enable proper comparisons that are also feasible in real world settings.  Measurement of intervention processes and impacts also is encouraged to enable assessment of intervention fidelity and whether hypothesized mediators were affected. Measurement of secondary outcomes such as social outcomes and possible co-benefits of physical activity participation (e.g., effects on behavioral, cognitive, or psychosocial outcomes; effects on substance abuse, tobacco use, mental health, or cardiovascular disease risk factors) or adverse outcomes (e.g., injuries) may also be included.

It is anticipated that each award will support multidisciplinary project teams composed of scientists with expertise to enable all the specific aims to be addressed. A range of disciplines is likely to be needed; for example, teams may include public health, clinical, behavioral, and social scientists, statisticians, exercise physiologists, and others. 

Section II. Award Information
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

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)

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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept 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.
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Application budgets must include funds for two investigators from each grant to attend one meeting of grantees annually, to be held in the Washington, DC area.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:  

Research Strategy: Investigators should describe how scalability and packaging could occur, or how the studies may influence policies and decision-making at multiple levels. Investigators should also justify the population group of interest and the suitability and tailoring of the intervention, physical activity goals, and measures for the target population. Investigators should pay close attention to the quality of measurement of physical activity, ensuring that the measures are reliable and sensitive to change at the population level.

Investigators should propose the strongest study design that can evaluate the effects of the intervention program with high internal validity, taking into account external validity and generalizability. In general, this would be a randomized controlled trial (RCT) design. Most studies proposed in response to this announcement will probably need randomization at the group level (Group Randomized Trial, or GRT) to match the level of intervention and to minimize or prevent contamination of the comparison group.  In some cases, a randomized design may not be possible or feasible, or would raise ethical concerns that are difficult to address. In such instances, investigators could propose and justify alternative, high-quality study designs. Such designs include, but are not limited to, quasi-experimental designs such as multiple baseline or time series, regression discontinuity, pre-to-post intervention with external comparison, natural experiments, or others..).

The statistical analysis and power calculations should reflect the design.  That is, if group randomization is used (GRT), the hierarchical nature of the data needs to be addressed, and the number of groups, not just individuals, needs to be considered.  If individual randomization is used, but participants will interact post-randomization either with each other in small groups or with a common change agent (Individually Randomized Group Treatment design, or IRGT), the hierarchical nature of the data needs to be addressed, and the number of groups or change agents, not just individuals, needs to be considered.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?   

Additional Review Criteria

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.

Study Design   

The committee should evaluate whether or not the study design can evaluate the effects of the intervention program with high internal validity, taking into account external validity and generalizability. In general, this would be a randomized controlled trial (RCT) design. If a randomized design is not possible or feasible, or would raise ethical concerns that are difficult to address, reviewers should evaluate whether alternative, high-quality study designs are proposed.)

The committee should also evaluate whether the statistical analysis and power calculations reflect the design appropriately.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

Additional Review Considerations

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

Not Applicable

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, 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 submitted in response to this FOA. 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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Barry Portnoy, Ph.D.
Office of Disease Prevention (ODP)
Telephone: 301-402-4337
Email: portnoyb@od.nih.gov

Lisa Onken, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2235
Email: Lisa.Onken@nih.gov

Frank Perna, Ed.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6782
Email: pernafm@mail.nih.gov

Lyndon Joseph, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: josephlj@mail.nih.gov

Beverly A. Ruffin, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0281
Email: Beverly.ruffin@nih.gov

Lynne Haverkos, M.D., M.P.H.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6881
Email: haverkol@mail.nih.gov

Maggie Brewinski Isaacs, M.D., M.P.H
Office of Research on Women's Health (ORWH)
Telephone: 301-451-7082
Email: Maggie.Brewinskiisaacs@nih.gov

Peer Review Contact(s)

Weijia Ni, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-3292
Email: niw@csr.nih.gov

Financial/Grants Management Contact(s)

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.nih.gov

Mahasin McCall
National Institute on Aging (NIA)
Telephone: 310-402-7736
Email: mccallm@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Diana Haikalis
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1373
Email: diana.haikalis@nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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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