Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title
Alcohol and Other Drug Interactions: Unintentional Injuries and Overdoses: Epidemiology and Prevention (R01 - Clinical Trial Optional)
Activity Code
R01 Research Project Grant
Announcement Type
Related Notices
  • March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
  • July 31, 2019 - Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [2nd Revision]. See Notice NOT-AA-19-020.
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity

PA-18-861, R03 Small Grant Program

PA-18-862, R21 Exploratory/Developmental Grant

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.273, 93.279
Funding Opportunity Purpose
The purpose of this funding announcement (FOA) issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) is to encourage research grant applications that explore whether and how alcohol and other illicit drugs or illicitly used prescription drugs interact to contribute to unintentional injuries and poisonings and how to prevent and/or reduce simultaneous use of alcohol or drugs singly or in combination.

Key Dates

Posted Date
July 19, 2018
Open Date (Earliest Submission Date)
September,05, 2018
Letter of Intent Due Date(s)
Not Applicable
Application Due Date(s)
Standard dates apply by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)
Standard AIDS dates apply by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date
September 08, 2021
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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 2. Full Text of Announcement

Section I. Funding Opportunity Description


The purpose of this funding announcement (FOA) issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) is to encourage research grant applications that explore whether and how alcohol and other illicit drugs or illicitly used prescription drugs interact to contribute to unintentional injuries and poisonings as well as violent behavior and suicide and how to prevent and/or reduce simultaneous use of alcohol and drugs and their consequences.

Prevalence of Simultaneous Alcohol and Drug Use

Simultaneous alcohol and other drug use is a common phenomenon. A latent class analysis of data from the Monitoring the Future study of high school seniors surveyed from 1976-2016 (N=84,805; average response rate=83%) identified the following in the past 12 months.

1) Heavier simultaneous alcohol (binge 5+ drinks) and marijuana (SAM) use (11.29%)

2) Lighter SAM use (21.6%)

3) Concurrent alcohol and marijuana use (10.7%)

4) Alcohol-only use (56.4%)

Compared to concurrent alcohol and marijuana users and alcohol-only users, heavy SAM users were more often white and male, had parents with some college education, had lower grades (C+ or lower), more frequent evenings out with friends, truancy, illicit drug use other than marijuana, and a lower likelihood of college attendance, and membership. SAM use was lower in the most recent cohorts (2006-2011), compared with the 1986-1995 and 1996-2005 cohorts. The study did not explore whether the heavy SAM users were more likely to be drivers after drinking in motor vehicle crashes after drinking, particularly crashes resulting in injury or experience overdoses from alcohol or drugs only or the two in combination. This clearly warrants exploration.


Alcohol misuse is the third leading cause of death in the United States, contributing to over 88,000 deaths annually from 2006-2010 and nearly $250 billion in annual costs in 2010 to the nation (over $750 per man, woman, and child). Of these deaths annually, 49,544 are injuries and poisonings, many of which are among young people (nearly 16,500 below age 35). Disproportionately common among young people, injury and poisoning deaths produce twice the number of preventable years of life lost as chronic disease alcohol attributable deaths. Annually, there are 130 million emergency department (ED) visits. In 2014, 4,976,136 involved alcohol, a 47% increase per 100,000 population since 2006, and those ED visits cost $8.7 million.

Alcohol can increase the risk of injury (e.g. by slowing the decision-making process, reducing visual acuity, increasing reaction time, depressing the cough reflex (increasing risk of choking and aspiration), impairing postural control, balance and gait, reducing the capacity swim and resist cold temperature, and increasing the odds of falling asleep while smoking and or failing to hear a smoke alarm. By increasing confidence, inhibiting self control, and impairing assessment of risk, alcohol may also indirectly increase the risk of injury and the likelihood that conflicts will escalate into violence. A case crossover study in which patients served as their own controls showed a nine-fold increase in the odds of injury among patients who reported consuming 5-6 drinks during a six-hour period before the injury and a 17-fold increase among patients consuming 7 or more drinks. One case control emergency department study found significantly elevated odds of injury in 10 of 11 body regions for all types of injury among women who consumed 4 or more drinks and men 5 or more drinks the preceding 24 hours, controlling for age.

The most common types of acute deaths attributable to alcohol misuse and possibly alcohol in combination with drugs are traffic crash deaths, poisoning/overdose deaths, violent behavior, homicides, and suicides, resulting in a total of 49,000 deaths annually. We will focus on those types of events for illustrative purposes, but many of the same etiologic and prevention strategy questions may apply to other types of unintentional injuries (e.g., falls, drownings, or burns).

Applicants who are interested in assignment to and funding by the National Institute on Drug Abuse (NIDA) should consult the "2016-2020 NIDA Strategic Plan" ( to verify that their research aims align with the Objectives and the Priority Focus Areas that NIDA is emphasizing.

Traffic Crashes

Traffic crashes have long been the predominant type of alcohol-attributable injury death. A review of over 100 laboratory studies found that impairment in the skills needed to safely operate a motor vehicle begins with any departure from 0% blood alcohol content (BAC). Virtually all drivers exhibit impairment on some critical driving measure at 0.08% BAC. Deficits included reduced peripheral vision, poor recovery from glare, poor performance in complex visual tracking and reduced divided attention performance. Driver simulation and road course studies reveal poor parking and driving performance at low speeds and road risk observational studies have identified increased deterioration of speeding and braking performance.

In 2016, 12,514 people were killed in motor vehicle traffic crashes that involved any alcohol. That year, 10,497 died in alcohol-impaired traffic crashes where at least one motor vehicle operator had a BAC of 0.08% or higher. The most recent comparison of alcohol test result for drivers in single vehicle fatal crashes versus those stopped at random in national roadside research surveys found that, compared to sober drivers the same age at BACs of 0.02-0.05%, the relative risk of single vehicle driver crash death was 3.8, 2.4, and 3.3, respectively, for drivers ages 16-20, 21-34, and 35 or older. At BACs of 0.08% to 0.09%, the increased risks were 31.9, 23, and 20.9, respectively. At BACs of 0.15%, risks were 4728, 2171, and 1664.

In a 2007 national roadside survey, the National Highway Traffic Safety Administration collected both driver breath alcohol samples and saliva and blood samples for drugs. At night on weekends, the percent that tested positive for drugs was higher than for alcohol (14% versus 12%). In 2013, 17.7% drove after drug use and 8.3% drove after drinking. In 2012, according to the Fatality Analysis Reporting System of the National Highway Traffic Safety Administration, more than 70% of fatally injured drivers in 18 states were tested for both alcohol and drugs. In those states, of fatally injured drivers with known test results, 54% tested negative for both alcohol and drugs, 38% were positive for alcohol, and 36% for drugs. Sixteen percent tested positive for both alcohol and drugs. Of the fatally injured drivers with positive drug test results, 64% tested positive for marijuana and smaller percentages tested positive for stimulants, narcotics, depressants, or other drugs. Of course, a high prevalence of drugs in surveys or fatal crashes does not necessarily mean presence of these drugs increases traffic crash risk.

Reviews of case-control, culpability, and cohort studies of traffic risks posed by driving after using single illicit or medical drugs illicitly indicate significantly increased risk but less than risk posed by driving after drinking at blood alcohol concentrations of 0.08% or higher, the U.S. standard of driving while intoxicated. Results across studies of drug driving are less consistent than results on drinking and driving. Although a recent NHTSA case/control study of 3,000 crash and 6,000 control drivers did not find an increase in crash risk when driving after marijuana and other drug use, analyses did not focus on fatal and injury crashes, the types of crashes most likely to involve alcohol, nor did they focus on single vehicle crashes where the driver would be more likely to be at fault. Nor did analyses separately focus on young drivers under 21, who are most at-risk for alcohol-related crash involvement. NHTSA is funding a new case/control study with cases being drivers in injury and fatal crashes. Review studies show higher crash risk if drugs are used in combination. Five recent reviews report the highest crash risk when drugs are used in combination with alcohol. One review reported a significant two-fold increase in crash risk if someone drove after marijuana use. A meta-analysis of nine studies, reported a significant 2.1 increased fatal crash risk and a 1.9 overall crash risk if drivers drove after marijuana use. Another meta-analysis found higher risks for driving after drug use of amphetamines, benzodiazepines, and cocaine than after marijuana use. The relative risk of fatal crash if drivers drove after marijuana use was 1.25 and not statistically significant. However, among the studies rated of highest methodological quality, the risk was 7.0.

The most recent review of epidemiologic studies found statistically significant increases in traffic crash risk for benzodiazepines and z-hypnotics (in 25/28 studies), cannabis (in 23/36 studies), opioids (in 17/25 studies), cocaine (5/9 studies), amphetamines (in 8/10 studies), and anti-depressants (9/13 studies). Simultaneous use of multiple drugs yielded higher traffic crash risk, and the highest crash risks were linked to simultaneous alcohol and drug use.

The largest recent multi-national European study examined 2,490 seriously injured drivers and 1,112 killed drivers compared to control samples of 15,832 and 21,917 drivers stopped at roadside surveys in the same countries and tested for alcohol and drugs.

No significantly increased risk was found for drivers positive for marijuana but a slight but significant increase for injury crashes was observed. The increased odds ratios ranged from 1-3 medium increased risk (2 to 10) for injury or fatal crash risk was observed for cocaine, benzodiazepines, and medical opioids. High increased risk (5 to 30) was observed in drivers positive for amphetamines or other drugs used in combination. The highest increased risk (20 to 200) was for alcohol at BACs of 0.12% and higher and alcohol in combination with drugs.

One meta-analysis of over 120 studies found frequent users of marijuana (unless used in conjunction with alcohol show less impairment at the same dose either because of phsysiologic tolerance or learned compensating driving behavior. Nonetheless, the higher the blood THC concentration, the greater the driving impairment. Evidence from laboratory studies on cannabis indicate impairment persists for some weeks after cessation, raising the possibility that both tests for recent and long-term cannabis use may be needed to evaluate crash risk linked to cannabis use, alone, with other drugs, and with alcohol.

A review of experimental laboratory studies published between 1998-2015 found decrements in behaviors related to safe operation of motor vehicle vehicles associated with benzodiazepines, cannabis, cocaine, opioids, GHB (a sedative and anxiolytic drug), ketamine, stimulants, and antihistamines each increase risks for impairment. Low doses of stimulants did not seem to cause impairment. Simultaneous alcohol and drug use was not explored.

Most recently, case/control and case/crossover analyses of adult emergency department injured patients (N=2,804) found that alcohol significantly increased injury risk in both types of analyses. Risk of injury were not significantly increased for marijuana, stimulants, and depressants. Combined alcohol and marijuana use produced marginally significant increased risk and significant increased risk for alcohol in combination with two or more drugs simultaneously consumed.

Limitations in some of the above studies include:

  • Low response rates
  • Different measures for cases (blood) and control (oral fluids)
  • Small sample sizes and low statistical power
  • Variability in length of time after crash and drug test administration
  • Use of inactive metabolites of THC
  • Inability to measure mode of administration of cannabis (inhaled versus oral)
  • Lack of control for potential confounding factors

An expert panel convened by the National Highway Traffic Safety Administration recommend 1) pharmacology/toxicology reviews of drug effects, 2) standard behavioral assessment of drivers under the influence of drugs and alcohol, and 3) epidemiologic studies and reviews.

Examples of research that are encouraged by the FOA are given below and are not meant to be exclusive.

Specific Areas of Research Interest

Key unanswered questions are:

  • Does driving after alcohol and drug use increase fatal, injury, and property damage crash risk, and are the risks the same for each type of crash?
  • Do risks increase additively, synergistically, or less than additively?
  • With which drugs does combined alcohol and drug use independently increase risk?
  • Does crash risk of drug used in combination increase more for some drug combinations?
  • Is there an increased risk for use of alcohol and multiple drugs in combination relative to alcohol and individual drugs?
  • What percent of people killed in crashes involving drug-using drivers and drug-and-alcohol-using drivers are persons other than the drug-using and drug-and-alcohol-using drivers?
  • All the questions cited above need to assess whether risks vary by age, gender, race/ethnicity, BAC level, drug level, history of drug or alcohol dependence or both.

Various types of studies exploring drug use and driving alone or in combination with alcohol could be undertaken.

  • Etiology studies:
  • Experimental studies of impairment on tasks needed to operate a motor vehicle safely
  • Road course studies
  • Culpability studies
  • Case/control analyses
  • Longitudinal studies
  • Prevention studies:

Studies on the effects of change in drug laws or drug involvement alone or in combination with alcohol, such as the following:

  • Per se laws, which make it illegal to drive after any illicit drug or medicine used outside physician prescribed recommendations. Currently, only 17 states have drug per se laws, whereas all states have 0.08% blood alcohol per se legal limits.
  • Administrative license revocation laws allowing police to seize the license at the scene of any driver refusing a roadside drug test or who fails.
  • Laws requiring impaired driving offenders to be assessed for both alcohol and drug dependence and successful treatment completion requirements before driver license reinstatement.
  • Studies of changes in drinking and driving laws should also explore the effects of those laws on alcohol and drug involvement in various levels of traffic crashes. For this to be feasible, higher percentages of fatally injured drivers in crashes will need to be tested in most states.
  • Improvements in roadside survey methods and in specific roadside tests for drugs in particular are needed.

See the National Institute on Drug Abuse's website for marijuana research priorities.

Intensive case studies of quasi-experimental community enforcement interventions will be needed to test which alcohol and drug driving enforcement strategies are most effective (e.g., publicized sobriety check points or saturation patrols).

Studies of multi-component community interventions studies are needed to assess what combination of enforcement, education, and treatment/counseling strategies are most effective, including publicity about risks of driving after drugs and alcohol in combination and highly publicized enforcement.

Combinations of speed and safety belt enforcement with alcohol and drug driving enforcement also need to be tested, and the impact of heightened speed enforcement, speed cameras, and safety belt checkpoints on reducing crash involvement of drivers using alcohol or drugs or both could be explored.

Alcohol and Overdoses


According to the Surgeon General (2016), in 2015 in the United States, 67 million people reported binge drinking, and 27 million used illegal drugs or misused prescription drugs. In 2016, there were over 60,000 drug overdose deaths.

Rates of overdose deaths have risen dramatically in the last three decades, primarily from sedatives and pain killers. Overdose fatalities now exceed traffic injury deaths. An estimated one in four of overdose deaths involve alcohol. Based on data from the Nationwide Inpatient Sample, a probability sample of community hospitals, 1.5 million patients were hospitalized in 2008 for an overdose, half of which involved alcohol. The acute toxic effects of alcohol are manifest in symptoms of alcohol poisoning, which include vomiting, slow and irregular breathing, hypothermia, and mental confusion.

Alcohol may play a more substantial role in overdoses attributed to other drugs. If people have co-occurring alcohol or drug problems, their judgment may be impaired, prompting them to take larger and potentially more lethal doses of alcohol or drugs. Alcohol pharmacologically interacts with a variety of illicit and prescription drugs, including opioids and related narcotic analgesics, sedatives, and tranquilizers. Also, BACs required for fatal overdose are lower when alcohol is combined with prescription drugs. ICD-9 codes require medical examiners and coroners to list drugs when present, which may prompt under-reporting of presence of alcohol relative to drugs when overdoses occur.

Specific Areas of Research Interest

Examples of research that are encouraged by this FOA are given below and are not meant to be exclusive:

  • In what states and cities are all overdose deaths routinely tested for both alcohol and drugs, and what are the percentage and types of overdose deaths that involve alcohol?
  • How can testing be increased in other cities/states?
  • Does the percent involving alcohol vary by type of drug either illicit or prescription drugs illicitly used?
  • Do these percentages vary by age, gender, and race/ethnicity?
  • What proportion of overdoses is unintentional, and does this vary by alcohol involvement?
  • How were drugs and alcohol involved in overdoses obtained?
  • What are the trends over time, and have there been greater increases in overdoses from drugs and alcohol in combination rather than drugs alone or alcohol alone?
  • What is the impact of various interventions to reduce overdoses, such as drug package informational inserts, prescription monitoring laws and registries?
  • What impact do various alcohol policies have on alcohol and drug-related overdoses (e.g., legal drinking age changes, changes in alcohol prices/taxes, outlet density, hours of sale, and monopoly versus privatized sales)?
  • What impact does recreational and medical marijuana legalization have on overdoses involving marijuana, other drugs, and alcohol. Has this increased the use of edibles and does that affect rates of overdose from alcohol and marijuana?
  • What impact do various drug driving laws have on drug overdose rates?
  • What is the impact of early age of drug and alcohol initiation on overdoses involving alcohol and drugs?


Alcohol and other drug (AOD) use in the commission of other-directed aggression and violent behavior

Survey research data often has found a strong relationship between alcohol use and the expression of violence including, for instance, physical assault. In addition, evidence from carefully controlled human laboratory research has increased understanding of how?and how much?alcohol consumption is related to displays of aggression in the laboratory. Several reviews have concluded that alcohol?s role in the expression of aggression, violence, and violent crime is best described as a causal one. In general, the experimental research has found that while alcohol consumption does not increase aggression for all persons and in all situations, it does tend to increase aggression for persons with specific traits, such as among those with lower levels of empathy and high dispositional aggressivity.

In the ?real? world, however, people who use alcohol often also use illicit or licit drugs and, sometimes such people engage in violent behavior. In recent years, study of the effects of alcohol and drug usage on intimate partner violence (IPV) has been conducted among patients in substance abuse treatment. Thus, one study found that the interaction of alcohol and cocaine use during the 90 days prior to treatment was associated with violence severity, a finding that was largely replicated in subsequent research by the same team. In addition, laboratory research conducted with social drinkers has found support for the hypothesis that alcohol is more likely to increase aggression in men who report higher, as opposed to lower, levels of past-year stimulant drug use,

Nevertheless, in cases of violence in which multiple substances may have been ingested, several methodological issues hamper a full understanding of which substance might be contributing to the violence. While human laboratory research holds the potential to clarify this matter, subjects in such experiments investigating, for instance, alcohol?s effects on aggression typically do not also ingest drugs as part of the experiment. As a result, little can be said with certainty about the effects of co-usage of alcohol and other drugs on violence expression. When alcohol and illicit drugs are used together, the observed effects would seem to depend on the particular substances involved. However, a review concluded that while alcohol clearly was the drug with the most evidence to support a direct intoxication-violence relationship, the literature concerning benzodiazepines, opiates, stimulants, and PCP suggested that personality factors were at least as important as pharmacological ones in explaining aggression. Moreover, some drugs appear to have varying effects at different doses.

Furthermore, since surveys that measure past violence victimization rarely measure whether a substance had been used by the perpetrator at the time of the violent event, the event-level contribution of substance use is difficult to determine from such an approach. Even when the survey instrument does investigate event-level substance use, most studies tend to focus on the correlates or outcomes of use of just one particular substance. However, the fact that use of any particular substance tends to be highly correlated with the use of other substances means that the effects on violence expression of alcohol, for example, often can be wrongly attributed to one of the other drugs ingested at the time of the event.

Approaches to prevention of alcohol- and drug-related violence

Some reductions in violence have been observed as a result of implementation of a range of environmental-, community-, family- and school-level alcohol prevention programs. However, in considering the effects of such interventions on involvement in violence among individuals who use both alcohol and drugs, a largely unexplored?but important?question is this: Does the AOD-using individual?s drug use level/frequency remain the same, or increase, or decrease following reductions in alcohol use? The research literature offers relatively few hints at an answer. Thus, a review that assessed the body of research on the effects of psychosocial?but not environmental?interventions for concurrent problem drinking and illicit drug users reported that no conclusions could be made regarding the relative effectiveness of different types of interventions owing to the paucity of data and low quality of the retrieved studies. A systematic review concluded that following treatment for illicit drug use, alcohol use may increase the patients? likelihood of relapsing to his/her primary drug of abuse, with a subgroup of such individuals possibly vulnerable to becoming primarily addicted to alcohol. In short, then, it is not clear that environmental-level?or even psychosocial prevention or treatment?interventions that are aimed at reducing alcohol use in concurrent AOD users will necessarily reduce or eliminate use of the other substance(s) being used by such individuals. To the extent that this reduction is not realized, it must be considered that the individual?s ongoing substance use is likely to continue to contribute to at least some expression of violence, although this clearly should be seen as an area ripe for future research.

Treatment of AOD users as violence prevention

Violent users of both alcohol and other drugs may have trouble remaining in or complying with substance use treatment regimens. For instance, in a study of alcohol dependent men?with and without concurrent illicit drug use?who had been arrested for IPV, randomly assigned to group behavioral therapies and followed for 12 weeks, concurrent AOD users attended significantly fewer treatment sessions, had significantly fewer percent days abstinence from alcohol use, and significantly more days of positive breathalyzer tests than did the alcohol-only users, as well as significantly more impairments in anger management styles. Thus, alcohol dependent men who continue to use illicit drugs may require additional interventions to effectively control their drug use and anger management.

Future research that uncovers prevention and treatment approaches with AOD-using individuals that show promise in also reducing intentional displays of violence is urgently needed.

Alcohol and other drug (AOD) use in attempted and completed suicides

During the last decade, suicide surpassed motor vehicle crashes as the leading cause of injury death in the United States. Suicide is the 10th leading cause of all deaths in the population as a whole and ranks higher among younger people. For instance, suicide is the third leading cause of death for adolescents ages 12-17 and young adults ages 18-24 and the second leading cause among those ages 25-34.

Alcohol and other drugs often play roles in attempted and completed suicides. An analysis of data from people aged 15-29 in European countries concluded that higher levels of alcohol use were associated with completed suicides. Data from more than 45,000 adolescents age 16 from 16 European countries revealed that teens who drink alcohol, use licit drugs, smoke marijuana or use other illicit drugs are more likely to attempt suicide. Further, odds ratios for attempting suicide approximately doubled with each additional drug used. During 2005-2007, 31% of U.S. suicides by multiple substance overdoses involved a mixture of alcohol and prescription drugs (National Center for Injury Prevention and Control. As for ED visits for drug-related suicide attempts, alcohol was involved in 11% of cases among adolescents and 30% among young adults in 2008 (SAMHSA, 2010bc). Numbers of ED visits for suicide attempts involving combined alcohol and drug use increased 51% for males of all ages and 15% for females of all ages from 2005-2009 (SAMHSA, 2011bc).

Using data from the Nationwide Inpatient Sample, a dataset comprised of roughly 8 million discharge records per year from a 20% sample of public hospitals across the country, a study examined the role of alcohol in hospitalizations for suicide-related drug poisonings (SRDP) in adolescents 12-17 and young adults 18-24 between 1999 and 2008. Among 12-17-year-olds, there were 14,615 hospitalizations for drug poisonings in 2008, 72% which were suicide-related. Among 18-24-year-olds, there were 32,471 hospitalizations for drug poisonings in 2008, 64% of which were suicide-related. Rates of SRDP stayed the same for adolescents and decreased for young adults across the decade. However, the percentage of SRDP involving a concomitant alcohol overdose increased for both age groups. Thus, the likelihood that an adolescent or young adult who attempts suicide via drug poisoning will also consume an excessive amount of alcohol during the event is on the increase.

In addition to substance use, suicide is associated with a range of psychiatric conditions. Patients suffering from obsessive-compulsive personality disorder, depression, anxiety disorders, PTSD, and other psychiatric conditions are at elevated risk for use and abuse of drugs and alcohol, and the addition of such substance abuse increases the odds of suicide attempts beyond the psychiatric conditions alone. The complicated interrelationships between psychiatric conditions, substance abuse, and suicide make it challenging for researchers to tease out the independent effects of substance use alone. Moreover, research suggests that many patients hospitalized for suicide attempts will make another attempt requiring hospitalization in the coming years, highlighting the importance of effectively treating the AOD use upon initial attempt.

Specific Areas of Research Interest

  • Pharmacologically, how does co-usage of alcohol and one or more of the various illicit drugs contribute to expressions of aggression and other- and self-directed violence, and to what extent is this association moderated by BAC phase, setting, and characteristics of the individual user?
  • Which of the various environmental-, community, and family-level approaches to alcohol prevention are the most effective in limiting expressions of other- and self-directed violence among individuals who use both alcohol and other drugs, and what are the mechanisms by which this reduction is realized?
  • How might drug-involved violence be influenced by physical proximity to alcohol outlets, and how might land use zoning approaches aimed at de-concentrating clusters of alcohol outlets affect frequency of drug-involved violence in adjacent blocks?
  • Does enrollment in alcohol treatment reduce frequency/severity of violence in those individuals who use both alcohol and other drugs, and if so, what are the mechanisms by which this reduction is realized?
  • For all prevention and treatment approaches mentioned above, are observed reductions in use of one substance (e.g., alcohol) accompanied by increases (i.e., substitution effect) in use of other substances (e.g., illicit drugs)?
See Section VIII. Other Information for award authorities and regulations.

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

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

Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

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

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)


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

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

3. Additional Information on Eligibility

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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
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.

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

R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to (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 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 on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact 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 the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

In addition, for applications proposing clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

In addition, for applications proposing clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications proposing clinical trials>

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, for applications proposing clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications proposing clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

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.

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.

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

As part of the scientific peer review, all applications:
  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain ?applicable clinical trials? on the Protocol Registration and Results System Information Website ( NIH expects registration of all trials whether required under the law or not. For more information, see

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see; and Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at

Cooperative Agreement Terms and Conditions of Award
Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, 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 on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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)

Finding Help Online: (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free) Customer Support (Questions regarding registration and submission, downloading forms and application packages)

Contact Center Telephone: 800-518-4726


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

Email: (preferred method of contact)

Telephone: 301-710-0267

Scientific/Research Contact(s)

Robert Freeman, Ph.D. (for overdose projects)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-8820

Gregory Bloss (for traffic safety projects)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865

Marsha Lopez, Ph.D. (for projects intended as NIDA submissions)
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1846

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 Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707

Jennifer Schermerhorn
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6704

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 Part 75.

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