Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
The Department of Defense (DoD)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Office of the Assistant Secretary of Defense for Health Affairs (OASD/HA)

Funding Opportunity Title

Prevention and Health Promotion Interventions to Prevent Alcohol and Other Drug Abuse and Associated Physical and Psychological Health Problems in U.S. Military Personnel, Veterans and their Families (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-13-012

Companion Funding Opportunity

RFA-DA-13-013, R34 Pilot and Feasibility Studies

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279, 93.273, 93.865 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is issued by NIDA, the Department of Defense (DoD), Office of the Assistant Secretary of Defense for Health Affairs (OASD/HA), and NIAAA. The purpose is to accelerate research on health promotion and prevention interventions with foci on reducing the onset and progression of alcohol, tobacco, and other drug use and abuse (including illicit and prescription drugs) and associated mental and physical health problems and on the promotion of health-enhancing behaviors among active-duty or recently separated (e.g., Iraq and Afghanistan) military troops, Veterans, and their families.

Key Dates
Posted Date

January 30, 2013

Open Date (Earliest Submission Date)

April 1, 2013

Letter of Intent Due Date(s)

April 1, 2013

Application Due Date(s)

May 1, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2013

Advisory Council Review

August 2013

Earliest Start Date

September 2013

Expiration Date

May 2, 2013

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

Purpose

This Funding Opportunity Announcement (FOA) seeks research applications to accelerate research on health promotion and prevention interventions focused on reducing the onset and progression of substance use and abuse (including alcohol, tobacco and illicit and prescription  drugs) and associated psychological and physical problems (e.g., post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), depression, anxiety, sleep disturbances, chronic pain, obesity, anger, risk taking, interpersonal violence) and the promotion of health enhancing behaviors (e.g., physical activity, proper nutrition,  adequate sleep, enhanced relationships) among  U.S. military personnel, Veterans and their Families.  This FOA can include but is not limited to research related to individuals who are serving or have served in Operation Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq) (OEF/OIF), and/or Operation New Dawn (OND).  In addition, research related to all phases of the military lifecycle (i.e., accession, readiness, mobilization,  deployment, redeployment, post-deployment, reconstitution, and separation) and all branches of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard) and Veterans are of interest.  National Guard and Reserve service members, Individual Augmentees and Families have been identified as special needs populations that are of particular interest due to limitations in health care support related to not being attached to a military installation, among other factors.   An Individual Augmentee is a United States military member assigned to a unit for the purpose of filling in for, or augmenting, members of that unit.

Background

U.S. military personnel and their Families have endured many challenges since September 11, 2001.  More than 1.6 million service members have been deployed in support of the war efforts OEF, OIF and OND.  These sustained combat operations have resulted in military personnel experiencing increased numbers and lengths of deployments and greater exposure to stressors, including exposure to death, risk to life, sustained threat of injury or actual injury, and the day-to-day and Family stress inherent in all phases of the military lifecycle (to include the deployment cycle) and transitions.  Negative life stress has been shown to be a major contributor to both the onset and exacerbation of substance abuse and psychological health problems and to be related to a variety of negative physical health outcomes including, cardiovascular disease, cancer and asthma.   Moreover, positive health behaviors such as physical activity, proper nutrition, adequate sleep, and improvements to social relationships, all have been shown to both reduce stress and improve physical and psychological health outcomes.

Alcohol and drug use, especially prescription drug abuse, and suicides among military personnel who have served in OEF/OIF are reaching epidemic proportions (Institute of Medicine, 2012).  For example, rates of active duty personnel reporting prescription drug misuse have increased, from 2 percent in 2002 to 11% in 2008 (Bray et al., 2009).  Binge drinking among active duty personnel increased from 35 percent in 1998 to 47% in 2008 (Bray et al., 2009).  The injuries sustained by active duty service members in theater differ from those of other conflicts in that they often involve explosions that can maim, cripple and cause traumatic brain injuries (TBI); many of these injuries would have been fatal in previous wars.  Effective prevention efforts for active duty personnel, Veterans and their Families are needed to address these serious health issues and the on-going stress associated with them as this is a major public health gap.  Given the numbers of past, current and future service members, Veterans and their Families are in need of  prevention and health promotion interventions to reduce the incidence and prevalence of health risking behaviors such as substance use disorders (SUD), researchers are encouraged: to develop new prevention/health promotion interventions; examine tested prevention and health promotion interventions currently in use with these populations; adapt and test existing evidence-based interventions that are likely to improve outcomes within these populations; and/or conduct studies of implementation processes with the potential of promoting the uptake of evidence-based practices within existing military programs (e.g., on-going training) or systems (e.g., health care).  Health care efficiencies may be gained by leveraging technological developments (e.g, internet or telephone monitoring of interventions, web-based screening) thus efforts to integrate these approaches are encouraged.

This FOA seeks research focused on the testing of currently used, development of new or adaptation of existing and evidence-based drug abuse prevention/health promotion interventions, and on the dissemination of efficacious and effective intervention through military programs and system.  Programs may address substance abuse alone or in combination with co-morbid psychological and physical health problems and health promotion across the Military Lifecycle for military personnel, Veterans and their Families.

The Military Lifecycle encompasses several stages from accession through separation from the military. The Military Lifecycle includes the deployment cycle: Train-up / Preparation, Mobilization, Deployment, Employment, Redeployment, Post-deployment and Reconstitution (e.g., Pincus, House, Christensen & Adler, 2005, Morris, 2006).  During the train-up/preparation stage individuals and units receive training and readiness activities to ensure that military personnel and their Families are prepared for extended deployments. At mobilization, units or individuals and their Families are alerted to the possibility of deployment and undergo preparation consisting of administrative actions, briefings, training, counseling, and medical evaluations.  Deployment refers to the actual move to and installation of the military personnel into the designated theater.  During the employment stage personnel perform their assigned mission. The redeployment stage involves preparations for returning personnel, equipment, and material to the home station and begins the process of reintegrating personnel into their pre-deployment environments.  The post-deployment stage consists of administrative actions, briefings, training, counseling, and medical evaluations to facilitate the continued successful reintegration of military personnel into their families and communities.  The reconstitution stage begins after completing post-deployment recovery and includes briefings, training, counseling, and medical evaluations aimed at continuing the process of reintegrating into Family, community, and where applicable, civilian jobs.

For the purpose of this FOA the Military Lifecycle has been condensed into four stages.  The four stages are: 1. Pre-deployment which combines accession, train-up/preparation, and mobilization; 2. Deployment which combines deployment and employment; 3. Re-integration which includes redeployment, post-deployment and reconstitution; and 4. Separation and post-separation, which refer to life after service. 

Pre-deployment

For the purposes of this FOA, the pre-deployment stage includes pre-accession and accession. It should be noted that during this stage the functional health of service members compares favorably with other civilian and military populations (Smith et al., 2007).    Battlemind training is an example of a pre-deployment universal prevention intervention developed by Army researchers that is designed to help foster resiliency and reduce stigma associated with help seeking behavior among Soldiers.  Military personnel receiving pre-deployment Battlemind training reported fewer psychological health problems during deployment (MHATV, 2008). 

Deployment

For the purposes of this FOA, deployment can include combat deployments, training deployments or exercises, peacekeeping missions, unaccompanied tours. Deployment is a major transition for the military member and Family, during which the military member must accommodate to the new environment, routines, tasks and the threat of physical harm or death.  Deployments usually involve an extended period of separation of service member and Family.  Several epidemiologic studies examined the well-being of deployed service members and suggested negative outcomes for substance abuse and psychological health. There was a significant increase in the prescribed use of behavioral health medications by the third deployment (MHAT VI, 2009), indicating a relationship between repeated deployments and increasing psychological health problems.  With regard to substance use and abuse, 2007 data showed that 8% reported using alcohol in theater and 1.4% reported using illegal drugs/substances (MHAT V, 2008).  Inhalants were also a problem with 3.8% of Soldiers having reported they huffed. Younger service members with combat exposures had increased rates of new-onset heavy weekly drinking, binge drinking, alcohol-related problems and increases in smoking initiation and relapse (Jacobson et al., 2008; Smith et al., 2008). Additionally, there was a multiple deployment effect associated with using alcohol, such that personnel were significantly more likely to report using alcohol in their second deployment as compared to their first deployment.  In addition to the effects of deployment on the military member, there is evidence of the effects on the Family.  For example, Gibbs et al. (2007) reported the rate of child maltreatment in families of U.S. Army enlisted personnel was 42% higher during combat than in non-deployment.  In sum, there are serious and adverse consequences of deployment on health, suggesting a window of opportunity for prevention interventions before SUD and or comorbid conditions become entrenched.  

Re-integration

The Department of Defense (DOD) mandates post-deployment screening to identify individual health care needs of service members at risk for behavioral health problems, including alcohol related-related problems.  Those screened in the period from three to six months after their return were referred for further assessment and care at significantly higher rates compared to their initial post-deployment screen (Milliken, Auchterlonie, & Hoge, 2007).  Clinicians identified 20% of active duty and 42% of reserve military personnel for psychological health referrals through the combined screenings.   Alcohol problems were frequently reported; however, very few were referred to alcohol treatment (Milliken, Auchterlonie, & Hoge, 2007).  In another study, three to four months post deployment, 25% of Army Soldiers who were members of brigade combat infantry teams screened positive for an alcohol misuse problem, 12% screened positive and exhibited alcohol-related problems, and exposure to atrocities predicted misuse of alcohol with alcohol-related behavioral problems (Wilk et al, 2010).  It is worth highlighting that post-deployment screening does not include questions about most illicit drug use, prescription drug misuse, or tobacco use.  As such, the rates of illicit or prescription drug misuse and disorders among returning troops is unclear. Additionally, military regulations regarding substance use may deter people from seeking treatment out of fear of jeopardizing their careers.  Guard, Reservists and Family members not living within close proximity to a Veterans Administration (VA) or military medical facility may also have difficulty accessing substance abuse treatment programs and services.  The period of post-deployment and reintegration is an opportunity for interventions to both prevent problems before they occur and to prevent escalation of problems, especially within the social context of peers and Family.  Screening, brief intervention and referral to treatment (SBIRT) is one evidence-based method that has been utilized for identification of problems and implementation of brief prevention and health promotion interventions.  This approach has promise for preventing the occurrence of or escalation of psychological and physical health problems, including drug abuse, thereby reducing the use of costly treatments. 

Separation and Post-Separation

This aspect of the deployment process presents vulnerability and opportunities for prevention and health promotion interventions to both prevent problems before they occur and to prevent the escalation of problems to drug abuse, psychological health disorders, physical ailments or co-morbid problems.  Those who separate from the service experience similar problems to those who return and stay in the service.  Of the first 299,585 OEF/OIF Veterans accessing the VA healthcare, the top two reasons for presentation were various types of somatic pain (primarily joint and back pain) and psychological health problems. Within the psychological health problem category the top three complaints in order were PTSD, Abuse of Drugs, and Depression (VHA Office of Public Health and Environmental Hazards, 2008).   There are recent findings from the Millennium Cohort Study (Littman, et al., in press) documenting increased rate of weight gain around the time of military discharge. Previous studies have reported higher rates of obesity in veterans.  These findings clearly highlight the need for evidence-based health promotion and prevention interventions targeting SUDs and comorbid psychological and physical health problems for Veterans.

Comorbidity

An important issue to consider is the high rates of comorbidity between SUDs, psychological disorders, and somatic complaints such as PTSD, depression, anxiety, chronic pain, etc.  Prevention interventions that target both drug use and abuse and co-morbid psychological and physical health problems are often clinically warranted.  Drug abuse prevention interventions have shown to have effects on a wide array of behaviors, including preventing or decreasing severity of psychological health problems (e.g., Connell & Dishion, 2008; Mason et al., 2007), conduct problems, and health risking sexual behaviors related to HIV/AIDS.  However, there are many approaches that have not been tested, as well as many evidence based prevention interventions that could be adapted for military personnel and their families at all stages of the DC. 

Stigma

Stigma associated with divulging psychological health problems and treatment in the military and VA health system is widely assumed, but not well documented (e.g., Hoge et al., 2004).  There is equal, if not greater stigma attached to divulging drug use and abuse problems.  This may reflect the low tolerance policies of the military regarding illegal drug use and abuse, placing military personnel seeking treatment for drug abuse at risk of being discharged and losing benefits.  These constraints make drug abuse in the military a difficult topic to study.  Because of these issues with stigma, prevention becomes very important in the military system, especially universal interventions, where everyone receives an intervention and no one is singled out as needing intervention.  Prevention interventions delivered in primary care clinics help minimize issues related to stigma.    

National Guard and Reserves: A Special Population

Military operations have been described as particularly difficult for Reserve and National Guard families who have less access to military support systems and fewer connections to other military families.  In addition, deployed Reserve and National Guard personnel with reported combat exposures are at increased risk of new-onset heavy weekly drinking, binge drinking, and alcohol-related problems (Jacobson et al., 2008).  It has already been noted that reserve component military personnel required more psychological health treatment upon their return in comparison to active duty personnel (Miliken et al., 2007). 

Research Objectives

In sum, the purpose of this FOA is to fund research that examines: (1) untested existing interventions; (2) the development and testing of new interventions; (3) the adaptation and testing of efficacious health promotion and prevention interventions for substance abuse and associated psychological and physical health problems, alone or in combination; or (4) the dissemination of effective interventions through military related programs and systems, for individual service members, groups, and  Families. Attention to building positive health habits involving physical activity, proper nutrition, adequate sleep, and/or improvements to social relationships to both reduce stress and improve physical and psychological health outcomes is of interest.

Research on all arms of the military Reserves, National Guard, and Veterans is relevant.  Research should consider the deployment cycle, from pre-deployment through separation, as this knowledge helps to define the nature and scope of the stress and challenges these populations are likely to experience as well as the intervention approaches that are most likely to be effective.  Research may address drug abuse alone or in combination with health or psychological health comorbidities in military personnel, Veterans, and/or their families to be considered responsive to this FOA.

Limits related to confidentiality concerning research data that involves reporting of illegal behavior by active duty military personnel has the potential to impact the generalizability of data collected from these individuals. Therefore, it is expected that studies using active duty populations will mainly focus on collection of outcomes of legal substances including prescription drug abuse. Studies conducted with Family members or Veterans may target the full range of drugs of misuse, including prescription drugs.

The primary objective of this FOA is to stimulate research on approaches for the prevention of drug use onset and progression to drug abuse and dependence, drug related problems (e.g., interpersonal and familial violence, and lost productivity), drug related psychological health problems and disorders and associated physical health problems among military personnel, Veterans and their Family members. Prevention interventions for substance use and abuse and associated difficulties can include universal, selective, indicated and tiered interventions. Universal prevention interventions are targeted to the general public or to a whole population group. Selective prevention interventions are targeted to individuals or subgroups of the population with defined risk factors for the development of substance abuse. Indicated prevention interventions are targeted to individuals or subgroups that are identified as having non-clinical but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction. A tiered approach to prevention interventions incorporates two or more of these levels of intervention with increasing intervention intensity for individuals at greater risk or with greater problem severity.

Applications may include: 1) trials of prevention/health promotion interventions already being utilized with military members, Veterans or their Families that have not been evaluated, 2) development and testing of new interventions, 3) adaptations of interventions shown to be efficacious with civilian populations for use with military personnel, Veterans, and their families; or 4) studies that examine implementation processes that promote the uptake of evidence based practices within military programs. Prevention interventions should focus on increasing resilience and intrapersonal, interpersonal and familial functioning in order to prevent drug use and abuse and associated adjustment problems.  Additionally, data suggests that some military members initiate tobacco use after entering military service (Nelson, 2008); interventions may also target environmental policies that have the potential to promote or impede tobacco use by military members. One major consideration is the military/Veteran context including the infrastructure and policies related to the provision of intervention services (e.g., Army Regulation 600-85: The Army Substance Abuse Program; http: //www.army.mil/USAPA/epubs/pdf/r600_85.pdf). 

Potential study topics for prevention and health promotion interventions include but are not limited to:

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information seehttp://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

For this FOA combined with the parallel R34 FOA (RFA-DA-13-013), the participating organizations intend to commit approximately $7.5 million (total costs) in Fiscal Year 2013 with which it is expected that 9 to 18 new grants will be funded across the two FOAs.  Specifically, in Fiscal Year 2013, NIDA intends to commit approximately $1.0 million (total costs), DoD intends to commit $5-10 million (total costs), and NIAAA intends to commit approximately $1.0 million (total costs).

Award Budget

Budgets for direct costs may not exceed $500,000 per year or $2,500,000 over a five-year project period.

Award Project Period

The maximum 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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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:

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:  ereider@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Eve E. Reider, Ph.D.
Health Scientist Administrator
Prevention Research Branch
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5185, MSC 9589
Bethesda, MD  20892-9589

*Send overnight mail to Rockville, MD 20852

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

Budget Component

The budget should include funds necessary for travel to and participation in an in-progress programmatic/science review, lasting not more than two days and including up to two overnight stays, for each year of the project's term.

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In-Progress Programmatic/Science Review Meeting

The principal investigator may be required to participate in an in-progress programmatic/science review. The PD(s)/PI(s) shall budget for, prepare for, and participate in an in-progress programmatic/science review, lasting not more than two days and including up to two overnight stays, for each year of the project's term. The invitation and format for the programmatic/science review will be provided by the funding agency at least ninety (90) days prior to the meeting. The meetings will generally be held in the Washington D.C./Bethesda/Ft. Detrick, MD area.      

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

All applications will initially be assigned to NIDA for review and selection processes.  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.   Representatives of NIDA, NIAAA,  and DoD OASD(HA) may attend the review.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Following receipt of applications agency representatives (NIDA, NIAAA, DoD OASD(HA)) will make decisions regarding mission relevance of applications.     . Following  the  initial peer review, decisions will be made regarding assignment of application to agencies  (NIDA, NIAAA, DoD OASD(HA)) for funding.  Applications recommended for funding will receive a second level of review by the appropriate national Advisory Council or Board or DoD OASD(HA) Joint Program Committee-5. The following will be considered in making funding decisions:

There are additional requirements that will need to be adhered to prior to award of applications selected for funding by the Department of Defense (DoD), Office of the Assistant Secretary of Defense for Health Affairs (OASD/HA) (http://www.usamraa.army.mil/pages/pdf/General_Guidelines_for_Awards_Funded_by_the_DoD.pdf) (See Section VI.1)

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.

There are additional requirements that will need to be adhered to prior to award for those applications chosen to be funded by the Department of Defense (DoD), Office of the Assistant Secretary of Defense for Health Affairs (OASD/HA); please see website (http://www.usamraa.army.mil/pages/pdf/General_Guidelines_for_Awards_Funded_by_the_DoD.pdf) for "General Guidelines for Awards Funded by the Department of Defense."

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Eve E. Reider, Ph.D.
Health Scientist Administrator
Prevention Research Branch
National Institute on Drug Abuse
Telephone: 301-402-1719
Email: ereider@mail.nih.gov

Aaron White, PhD
Health Scientist Administrator
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-451-5943
Email: aaron.white@nih.gov

Katharine W. Nassauer, Ph.D.
Portfolio Manager, Psychological Health and Resilience US Army Medical Research and Materiel Command Military Operational Medicine Research Program
Telephone: 301-619-8973
Email: kate.nassauer@us.army.mil

Peer Review Contact(s)

Gabriel B. Fosu, Ph. D.
Scientific Review Officer
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 3108 MSC 7808
Bethesda, MD 20892 (20817 for overnight delivery)
Telephone: 301-435-3562
Email: fosug@csr.nih.gov

Financial/Grants Management Contact(s)

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse
Telephone: 301- 774-3803
Email: mconnell@nida.nih.gov

Judy S. Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
Telephone:  301-443-4704
Email:  jfox@mail.nih.gov

Susan Dellinger
Grants Officer
U.S. Army Medical Research Acquisition Activity
Telephone: 301-619-2090
Email:  susan.dellinger@us.army.mil

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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