Part 1. Overview Information

Participating Organization(s) National Institutes of Health (NIH) Components of Participating Organizations National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women’s Health (ORWH) Funding Opportunity Title Research on the Health Determinants and Consequences of Violence and its Prevention, Particularly Firearm Violence (R01) Activity Code R01 Research Project Grant Announcement Type New 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 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. Funding Opportunity Announcement (FOA) Number PA-13-363 Companion Funding Opportunity PA-13-368, R03 Small Grant Program

PA-13-369, R21 Exploratory/Developmental Grant Number of Applications See Section III. 3. Additional Information on Eligibility. Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.273, 93.865, 93.279, 93.242, 93.307, 93.313 Funding Opportunity Purpose This funding opportunity announcement (FOA) spans across the missions of several NIH Institutes and Centers (ICs) and Offices, and includes basic neuroscience and basic behavioral research, clinical and translational studies, intervention development at the individual, family and community level, efficacy trials of interventions based on evidence from basic and translational studies, and research to identify the best ways to disseminate and implement efficacious and evidence-based interventions in real-world settings. While this FOA covers all of the areas mentioned above, particular consideration will be given to applications that propose studies of the intersection that focus on the various types of violence (homicide, suicide, youth and gang-related, intimate partner) and firearms.

Key Dates

Posted Date September 27, 2013 Open Date (Earliest Submission Date) January 5, 2014 Letter of Intent Due Date(s) Not Applicable Application Due Date(s) Standard dates apply, 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) Standard AIDS dates apply, 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. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 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.

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

Background and Purpose

This funding Opportunity Announcement (FOA) is intended to support research projects that will examine the etiology and consequences of violence as they relate to the health of individuals and communities. In addition, it will provide support for research projects that rigorously test the efficacy and effectiveness of interventions to prevent violence and its precursors, using strong empirical designs. Finally, it will support studies to enhance effective dissemination and implementation of evidence-based strategies into clinical and community settings.

For this FOA, violence is defined as “the intentional use of physical force or power, threatened or actual, against oneself, another person, or against a group or community that either results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation.”(World Report on Violence and Health, 2002).

While violence-related research has been ongoing at NIH for many years, a number of expert meetings and reports generated by scientific health policy and research organizations including the World Health Organization (2010; 2002), the Institute of Medicine and the National Research Council (2003), the National Institutes of Health (2004), the National Academies of Science (2004, 2010, 2011, 2012a, 2012b), the Centers for Disease Control and Prevention (2009) and the National Institute of Justice (2011) have explicated the need for additional, comprehensive, and rigorously designed studies to advance understanding of the underlying behavioral, neural, and genetic mechanisms of violence; public health impacts (including individual and societal costs) of violence; the cognitive, behavioral, pharmacological, determinants of violence; risk and protective factors at the individual, family, and community level; the development and testing of safe, effective and cost effective interventions to reduce and/or prevent violence and its precursors, and the best strategies to increase adoption and implementation of evidence-based interventions. Further research is warranted in these areas as applied to all types of violence, particularly in the case of firearm violence, which has such high morbidity and mortality. At the request of the Center for Disease Control (CDC), the Institute of Medicine recently developed a proposed public health research agenda to improve knowledge of the causes of firearm violence, the interventions that prevent firearm violence, and strategies to minimize the public health burden of firearm violence (2013).

According to the World Health Organization (2010) violence is responsible for 1.6 million deaths annually worldwide. In the United States in 2009 almost 16,800 people were victims of homicide and an additional nearly 37,000 took their own life (CDC, 2009). In 2010, 11,078 individuals died by firearm homicide, while 19,932 died by firearm suicide (http://www.cdc.gov/injury/wisqars/pdf/10LCID_Violence_Related_Injury_Deaths_2010-a.pdf). For many more individuals experiencing or witnessing a violent event,, violence contributes to acute and chronic health and mental health consequences. A critical consideration for research and prevention is that violence occurs in different forms and at varying risk levels throughout the life course, with important implications for human development. It is important to distinguish between exposure to chronic violence and exposure to episodic violent events, as these affect health differently.

More than 50% of all suicides involve the use of a firearm and firearms were used in 44% of suicide deaths among persons under the age of 25 in 2010 (National Center for Injury Prevention and Control, 2012). Research has shown that the risk of youth suicide increases in homes where firearms are kept unlocked and/or loaded . However, more consistent survey measurement approaches would allow for refined analyses that could enhance the understanding of the role of storage of firearms on mortality risk for all age groups .

Intimate partner violence can be fatal when a firearm is involved. Female homicide victimization rates have been significantly associated with firearm availability . The overall number of firearm homicides among intimates has fallen considerably during the past 30 years, but more should be understood about why this has happened and how this knowledge might inform new strategies to reduce firearm violence.

Scope

Several NIH ICs and components of the Office of the Director are participating in this FOA. The FOA supports studies that include the violence, injury and death that occur as a result of firearms, and the particular populations most affected by armed violence throughout the human lifespan. The scope of the FOA also includes, but is not limited to intimate partner violence, youth violence (including gang violence), and self-directed violence (suicide). The subject of this FOA spans across the missions of several NIH Institutes, Offices, and Centers (ICs) and includes basic neuroscience and basic behavioral research, clinical and translational studies, intervention development at the individual, family, and community level, efficacy trials of interventions based on evidence from basic and translational studies, and research to identify the best ways to disseminate and implement efficacious and evidence based interventions in real-world settings. While this FOA covers all of the areas mentioned above, particular consideration will be given to applications that propose studies of the intersection that focus on the various types of violence (homicide, suicide, youth and gang-related, intimate partner) and firearms.

Following are topic areas that are of particular interest to each IC.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The NIAAA welcomes applications that explore the etiology, epidemiology, prevention, and treatment of alcohol-related violence as described below.

Etiological studies, including those utilizing experimental (human laboratory), survey, modeling, and/or GIS research approaches that might: Elucidate the complex relationships between alcohol use and violence. Increase understanding of whether and how individual and environmental conditions, situations, and alcohol use may be causally connected to violence—including intimate partner violence (IPV) and sexual assault. Delineate significant associations between the locations of alcohol outlets and rates of violent and criminal events in surrounding areas. Investigate the role of alcohol use in attempted and completed suicides and firearm violence. Delineate the various processes—including societal reactions, stigma, and psychological distress—by which heavy drinking may be a consequence of victimization experience, including victimization that may begin as early as childhood.

Epidemiological studies that might: Elucidate the size, correlates, and trends in alcohol-related IPV. Determine whether the occurrence of alcohol-related violence is following the general downward trend in other forms of violence observed in recent decades.

Preventive intervention studies that might: Investigate the effects of legal and policy approaches to alcohol-related violence. Assess changes in observed alcohol-related violence as a result of implementation of a range of environmental-, community-, family- and school-level alcohol use prevention programs. Explore which of these various approaches to alcohol prevention are the most effective in limiting expressions of violence among individuals who use both alcohol and other drugs. As few preventive interventions that specifically address the role of alcohol use in IPV exist, the market for such interventions is great, extending from college campuses to military bases and beyond. Potential interventions for alcohol-related Violence Against Women (VAW) might be situated in hospital emergency rooms or other settings in which victimized and at-risk women are likely to appear, and may be aimed at perpetrators of VAW as well as at potential victims. Interventions to prevent alcohol-related violence may focus on the alcohol component of the problem, the violence component, or both simultaneously.

Focus on: Specific dimensions of the environment (e.g., bars) in which alcohol is distributed, sold, and consumed. Groups or individuals who are at elevated risk. Families, significant others or peer groups of persons who may be at increased risk.



Studies should be designed as to permit identification of mediating/ moderating factors that may reduce alcohol-related violence. Investigators are encouraged to take advantage of opportunities to test or evaluate interventions that occur (or have occurred) "naturally" in the community or society, such as changes in laws, police monitoring, initiation/ enforcement of responsible beverage service, community-wide campaigns similar to those that have focused on reducing drunk driving, and changes in land use zoning laws. Alternatively, researchers may choose to design, develop, modify, or adapt the interventions that they plan to test. Prevention approaches might be applied universally, or aimed at targeted or indicated individuals.

Treatment proposals that might: Focus on the mechanisms by which treatment of alcohol dependent individuals—using pharmacological or behavioral approaches—might reduce displays of violence Explore the effects of intimate partner violence on the willingness to pursue substance abuse treatment/counseling Investigate how substance use treatment counselors might become more sensitive and responsive to the victimization histories of their clients.



Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NICHD is interested in applications that explore short- and long-term consequences of child maltreatment, violence, and exposure to violence on the family and children. Applications may address, but not be limited to the following research objectives:

Research on the range and intensity of violence: The nature of violence exposure including the range, intensity and outcomes of violence exposure (e.g., from verbal aggression through homicide; physical injuries and disabilities). The range of behaviors involved (e.g., psychological control, threat of violence). The timing and patterning of exposure (e.g., age of onset, frequency of exposure, acute versus chronic episodes, coincidence with important developmental transitions). The severity of exposure and the child's degree of involvement (e.g., type of sensory input, such as directly seeing or hearing from another room, the child's reaction such as attempts to intervene and outcomes/consequences of these reactions ).

Research on the co-occurrence of violence and violence exposure: The co-occurrence of children’s exposure to these types of violence (e.g., domestic and community violence). The co-occurrence of violence exposure with other types of violence (e.g., child abuse, sibling abuse, bullying, violence against sexual and gender minority youth, gang violence). The co-occurrence of violence exposure with other risk factors (e.g., poverty, parental monitoring, military family status, parental substance abuse or displacement from the home).

Factors affecting child responses to violence: Biological, psychological, and socio-environmental factors that affect child and adolescent responses to violence and violence exposure (e.g., child cognitions/attributions, family organization and relationships, parent mental health status, poverty, affluence, stress and stress disorders, school or community characteristics.

Research on prevention and intervention programs and services for children exposed to violence, including studies of: Children's contacts with formal (e.g., healthcare, mental health, educational, child protection, and criminal justice) and informal (e.g., relatives, neighbors, and religious and community groups) systems and consequences of these contacts for children and families. Emergency medical services to children exposed to and directly affected by violence. The impact and consequences of types of media exposure on child and adolescent mental health and behavioral outcomes. Knowledge and behaviors of health care providers or other service personnel that influence early detection of susceptibility and exposure to violence. Development and validation of biomarkers, indices or classificatory systems that aid health providers, teachers or other community members to recognize children exposed to violence or at risk for violence perpetration or victimization.



National Institute on Drug Abuse (NIDA)

High priority topics for NIDA include:

Research that examines the relationship of drug use and abuse to violence particularly focusing on child maltreatment, gang involvement, intimate partner violence (IPV), family violence, drug -related sexual assault, the justice system (including criminal justice, juvenile justice and drug courts), bullying and other violent behavior including the use of firearms.

Research to understand the genetic, epigenetic, neurobiological, and behavior basis of substance use related violence that could inform prevention, treatment and services delivery research including a focus on gender differences and health disparities. This may address drug use in general or the use of marijuana, prescription drugs, drug combinations, newly emerging drugs of abuse (including bath salts and other “designer drugs”), and other specific drugs of abuse, particularly drugs showing escalated use or high prevalence of use in adolescents or other subpopulations (e.g., young adults, military personnel) .

Research on the role of co-morbid psychiatric and substance use disorders in relation to violence and risk for violence, victimization, and perpetration. Building on current studies to improve data collection including collecting data on possession, access and use of firearms, policies related to firearm access with co-occurring prevalence of violent and aggressive behavior and risk, developmental disorders, drug abuse and psychiatric disorder to assess the extent of the problem and inform the development of targeted prevention and treatment interventions.

Development and testing of interventions to prevent substance use/problems and substance use related risk behaviors among vulnerable populations at risk for victimization as well as children and youth who are exposed to maltreatment, violence, and victimization, including witnessing of firearm violence in their home settings and communities.

Research to examine structural and community factors associated with substance use and violence and development and testing of structural and community prevention interventions to prevent various forms of violence, including firearm violence.

Research to develop and test substance abuse treatment interventions for victims and perpetrators of violence, particularly those with co-occurring substance use and psychiatric disorders, including interventions for victims of IPV.

Studies on development, testing and integration of evidence based interventions that address substance use and violence in health care settings.

Examination of the role of media, social media and new and emerging technologies (smart phones, video games) on substance use and violent behaviors and the use of social media and new/emerging technologies as a platform to deliver violence prevention and treatment interventions.

National Institute of General Medical Sciences (NIGMS)

Topics of interest for NIGMS focus mainly of the individual’s physiological response to injury caused by violence and in large part be based within the emergency setting, including:

Physical trauma impacts multiple organs systems, and the prior internal condition of these systems has significant bearing on the ability of the individual to respond to injury. For example, neural circuits underlie cognition, behavior and emotion. These systems and dependent functions are altered by physical damage as well as by environmental stressors that may be immediate or long term in nature. Recent insights have revealed the close connections between brain and peripheral pathways and the inflammatory and immune responses, in effect providing direct linkage between the state of the brain and the overall physiological condition of the body. Better understanding of how damaged or altered hormonal pathways (from any source, immediate or longer term) interact with systemic or local host response mechanism will have important ramifications for post-violence mortality and morbidity. Similarly, long term exposure to any number of external stressors (such as exposure to violence) impinge and modify many internal physiological systems, and thus alter the immediate response to and prolonged recovery from injury.

NIGMS is also interested in the application of computational and systems approaches to understanding and modeling the prevention, determinants, and consequences of violence from the cellular to individual behavioral and societal scale.

National Institute of Mental Health (NIMH)

The NIMH supports research across several Divisions that may be relevant to research as described in this FOA. NIMH will accept and consider funding applications focused solely on the intersection of mental illness and violence. Priority areas of interest are limited to:

Research to identify the mechanisms (e.g., biological, genetic, psychological, and behavioral) that give rise to, and the developmental and neurobiological trajectories that lead to, mental illness (e.g., posttraumatic, mood, and anxiety spectrum conditions) following exposure to violence (e.g., injury, mass trauma, IPV, etc) across the lifespan.

Research on the development and testing of strategies to prevent and treat the mental illness that may occur as the result of violence.

Research to develop and test strategies to reduce the duration of untreated psychosis such that individuals at-risk for serious mental illness are engaged in treatment as early as possible in order to reduce long term negative consequences of illness, including risk for violence (self- or other-directed).

Research to develop and test interventions during the psychosis prodrome period to reduce conversion to psychosis and reduce the long term negative consequences of serious mental illness, including risk for violence (self, or other directed).

Research to advance suicide prevention, including research that tests the immediate and longer term benefits of separating lethal means from suicidal individuals while considering what is most feasible in care systems (e.g., pediatric care; residential treatment), educational and justice institutions.

Applicants interested in submitting clinical trials are strongly encouraged to consult with Program Staff well in advance of a submission. Experimental medicine type trials (medication and psychosocial) for proof of concept efforts to demonstrate target engagement, safety, and early signs of efficacy will be viewed as high priority (see http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml). Applications proposing clinical trials to evaluate interventions to prevent or treat mental illness associated with violence should specify which psychological constructs, neurocognitive operations, or biological variables (i.e., “mechanisms") are thought to underlie the mental illness under investigation. Applicants must describe how the proposed intervention is expected to impact hypothesized mechanisms, and how this relationship will be measured. When relevant, investigators are encouraged to conceptualize their research using the constructs and units of analysis defined in the Research Domain Criteria framework (http://www.nimh.nih.gov/research-priorities/rdoc/index.shtm).

For additional information on NIMH interests, opportunities, and contacts see http://www.nimh.nih.gov/about/organization/nimh-extramural-research-programs.shtml and http://www.nimh.nih.gov/about/organization/extramural-programs-and-contacts-listed-by-division.shtml\.

For specific priorities pertaining to suicide prevention, see: http://actionallianceforsuicideprevention.org/task-force/research-prioritization.

National Institute on Minority Health and Health Disparities (NIMHD)

High priority topics for NIMHD include, but are not limited to the following:

Research addressing the factors contributing to the persistence of firearm deaths within racial/ethnic communities and other health disparity communities.

Interventions that respond to, understand, improve and promote the mental health needs of affected by firearm violence especially those in health disparity communities.

Research that include pilot studies and qualitative techniques to understand the determinants of individual behavior, especially among adolescents and young adults, including the roles of social norms, networks, and neighborhood conditions which need to be more fully understood, so that interventions target appropriate behaviors.

Research that include meaningful partnerships between researchers and community-based professionals in law enforcement, criminal justice and public health for developing evidence-based interventions to reduce violence.

Research that explores innovative and rigorous study designs and identifies standards of evidence that are suitable for evaluating evolving programs and community-based research. For example, complementing area-level violence studies with offender-level data may allow a more detailed examination of crime displacement and deterrence. In addition conducting qualitative studies with offenders to better understand how risk perception and group norms affect firearm-related behavior.

Development of culturally appropriate, evidence-based health strategies to reduce violence for health disparities populations and disadvantaged communities.

Research on poverty, adverse childhood experiences and adult violent behavior, specifically focusing on parental protective practices and family resilience.

Research on risk and protective factors associated with residential housing segregation (urban, suburban, rural) and government-subsidized housing programs.

National Center for Complementary and Alternative Medicine (NCCAM)

Research on the efficacy and safety of complementary approaches (e.g., mindfulness/meditative approaches, yoga, tai chi) for pain management or for emotional regulation, using traditional or novel approaches involving new and emerging technologies (social media, device apps, smartphones, video games, virtual reality) are high priority research areas for NCCAM. In particular:

Individuals with chronic pain appear to have twice the rate of suicide than those without chronic pain. In addition chronic migraines, back pain, and psychogenic pain have been linked to suicide in veterans. NCCAM, therefore, is interested in studies designed to identify, or study the impact of complementary interventions, on mediating/moderating factors (e.g., resilience, and cognitive appraisal) that may reduce the salience of pain, catastrophizing, symptoms of depression, and, importantly, suicidal ideation. Research in elderly or veteran populations is of special interest in the context of this FOA.

Research on complementary approaches to promote psychological resilience and emotion regulation or distress tolerance in those at risk for, or exposed to maltreatment, victimization, traumatic stress, and violence, including firearm violence. Research in youth, military, and veteran populations is of special interest in the context of this FOA.

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

Renewal

Resubmission

Revision 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 total project period may not exceed 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)

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

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.

. 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. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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.







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, 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

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.

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:

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 Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.





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 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?

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.

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 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 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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp

TTY: 301-451-5939

Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)

Contact Center Phone: 800-518-4726

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)

Telephone 301-945-7573

TTY 301-451-5936

Email: GrantsInfo@nih.gov





Scientific/Research Contact(s)

Eve E. Reider, PhD

National Center for Complementary & Integrative Health (NCCIH)

Telephone: 301-443-8374

Email: ereider@mail.nih.gov

Robert C. Freeman, Ph.D.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Telephone: 301-443-8820

Email: rfreeman@mail.nih.gov

Valerie Maholmes, Ph.D., CAS

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: (301) 496-1514

Email: maholmev@mail.nih.gov

Jacqueline Lloyd, Ph.D.

National Institute on Drug Abuse (NIDA)

Telephone: 301-443-8892

Email: lloydj2@nida.nih.gov

Jeremy Brown MD

National Institute of General Medical Sciences (NIGMS)

Telephone: 301-594-4481

Email: jeremy.brown@nih.gov

Amy B. Goldstein, PhD

National Institute of Mental Health (NIMH)

Telephone: 301-496-7227

Email: goldsteinam@mail.nih.gov

Irene Dankwa-Mullan, MD, MPH

National Institute on Minority Health and Health Disparities (NIMHD)

Telephone: 301-401-1366

Email dankwamullani@mail.nih.gov

William Elwood

Office of Behavioral and Social Sciences Research (OBSSR)

Telephone: 301-402-0116

Email: william.elwood@nih.gov

Erica Spotts

Office of Behavioral and Social Sciences Research (OBSSR)

Telephone: 301-594-2105

Email: spottse@od.nih.gov

Denise Stredrick, Ph.D.

Office of Disease Prevention (ODP)

Telephone: 301-496-5979

Email: stredrid@od.nih.gov



Lisa Begg, Dr.P.H., R.N.

Office of Research on Women’s Health (ORWH)

Telephone: 301-496-7853

Email: BeggL@OD.NIH.GOV

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Judy S. Fox

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Telephone: 301-443-4704

Email: Judy.Fox@nih.gov

Bryan S. Clark, M.B.A.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-435-6975

Email: Bryan.Clark@nih.gov

Maryellen Connell

National Institute on Drug Abuse (NIDA)

Telephone: 301-774-3803

Email: mconnell@nida.nih.gov

Lisa Moeller

National Institute of General Medical Sciences (NIGMS)

Telephone: 301-594-3914

Email: moellerl@nigms.nih.gov

Tamara Kees

National Institute of Mental Health (NIMH)

Telephone: 301-443-8811

Email: tkees@mail.nih.gov

Priscilla Grant, JD

National Institute on Minority Health and Health Disparities (NIMHD)

Telephone: 301-594-8412

Email: grantp@mail.nih.gov





Shelley Carow

National Center for Complementary and Integrative Health (NCCIH) (Previously NCCAM)

Telephone: 301-594-3788

Email: CarowS@MAIL.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.