Expired PA-14-188: Epidemiology and Prevention in Alcohol Research (R21)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Funding Opportunity Title	Epidemiology and Prevention in Alcohol Research (R21)
Activity Code	R21 Exploratory/Developmental Research Grant
Announcement Type	Reissue of PA-11-018
Related Notices	November 27, 2017 - This PA has been reissued as PA-18-391. August 7, 2017 - Notice to Extend the Expiration Date for PA-14-188. See Notice NOT-AA-17-011. May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PA-14-188
Companion Funding Opportunity	PA-14-190, R01 Research Project Grant PA-14-189, R03 Small Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.273
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) encourages the submission of investigator-initiated research grant applications to support research investigating the epidemiology of alcohol use, alcohol-related harms, and alcohol use disorders and the prevention of underage drinking, alcohol-related harms, and alcohol use disorders.

Key Dates

Posted Date	April 24, 2014
Open Date (Earliest Submission Date)	September 16, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	New Date November 27, 2017 per issuance of PA-18-391. (Original Expiration Date: January 8, 2018)
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

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Epidemiology

Alcohol misuse is the fourth leading cause of death in the United States, resulting in an annual average of 87,798 deaths from 2006 to 2010. These represent 2.56 million years of potential life lost (1). Disability adjusted life years reflect a combination of years of life lost (YLL) to premature mortality and years of life lived with disability (YLD). Of seventeen risk factors, alcohol use ranks as the seventh leading cause of DALY’s in 2010, accounting for 5% of the total (2).

The estimated economic cost of excessive drinking was $223.5 billion in 2006, 72.2% from lost productivity, 11% from health care costs, 9.4% from criminal justice costs, and 7.5% from other effects. Or a per capita basis, this cost is approximately $746 for each man, woman, and child in the United States. Overall, $170.7 billion (76.4%) of total costs resulted from binge drinking, $27 billion (12.1%) from underage drinking, and $5.2 billion (2.3%) from drinking while pregnant. Notably, $130.7 billion (58.5%) of costs are born by people other than the drinkers ($92.9 billion, 41.2%) by federal, state, or local government.

Recent research has linked early age of drinking onset to development of alcohol dependence and injuring oneself and others after drinking. Though more research is needed to establish causality, prospective studies now have identified associations between alcohol advertising and promotions and portrayal in the media with earlier onset of drinking and development of having problematic drinking. Parental provision of alcohol to their children has also been associated with earlier onset of drinking and heavier drinking. This is of particular concern given the growing body of research prospectively linking heavy adolescent alcohol use and cognitive problems with memory, spatial relations and executive functioning as well as poorer academic performance. It is also recognized that fatal crash risk increases more rapidly with elevation of blood alcohol level among adolescent than adult drivers.

Epidemiologic research also identifies risk and protective factors for heavy drinking and alcohol use disorders. The best studies combine risk and protective factors at the individual, familial, small group, and environmental levels. In regard to the environmental level, many interesting contributions have recently been made through spatial modeling studies.

Genetic studies are making progress in understanding the interaction between contributions of biological and behavioral factors, and social-environmental contexts toward the development of alcohol use disorders. To increase the availability of comparable data across genomic studies, NIAAA encourages the use of measures contained in the PhenX Toolkit, an NIH-developed set of standard measures of phenotypic traits and environmental exposures.

NIAAA is interested in innovative research in these domains.

Prevention

The key potential benefit of research findings on the rates, developmental patterns, and risk and protective factors of alcohol use and alcohol-related problems is that they will provide a scientific basis for the development of more effective prevention strategies. Indeed an often-neglected task in translational research is making the link between findings of etiological processes and the development and testing of prevention strategies that play on those processes.

Recent research findings are helping to reduce alcohol-related traffic deaths and underage drinking. Substantial progress has been made in reducing alcohol-related traffic deaths in the United States. In 1982, 24,025 people died in traffic crashes involving at least one driver with a BAC of 0.01%, being 55% of all traffic deaths. That total declined to 11,510 (36%) in 2011, a 52% proportional decline. Those same years, the numbers who died in crashes involving drivers with a BAC of 0.08% or higher declined from 21,113 (48%) to 9,878 (31%), a 53% proportional decline. In contrast, fatal crashes with no alcohol involvement increased 5% from 19,771 to 20,752.

It has been reported that reductions in drinking and driving have prevented over 300,000 deaths during this time period, more than the total attributed to increased use of seat belts, air bags, and motorcycle and bicycle helmets combined.

The greatest proportional decline in traffic deaths involve drinking drivers during this period was among 16-20 year olds, down 77% from 4,436 to 1,030.

Research has identified a number of policy changes that reduce alcohol-related traffic deaths during this time period, including lowering the legal blood alcohol limit to 0.08%, criminal per se legislation, administrative license revocation, and mandatory safety belt laws, particularly primary enforcement safety belt laws.

Further, in 1984, Congress passed legislation to withhold highway construction fund to states that did not make it illegal to sell alcohol to people under age 21. By 1988, all states had done so. Also, in 2005, Congress passed legislation to withhold highway construction funds from states that did not make it illegal for people under 21 to drive with any measurable level of alcohol in their system, and by 1998, all states had done so. Numerous studies found both laws reduce alcohol-related traffic deaths under 21. More recent research suggests use/lose laws, internal possession laws, graduated driver licensing, and night driving restrictions can further reduce underage Drinking and driving.

To further reduce underage Drinking and driving, research supporting the effectiveness of individually oriented interventions, such as screening and brief motivational counseling intervention, expanded considerably. Family parent initiatives in the middle-school years can have effects enduring to age 21, and parental interventions, even with college students, may hold promise. Web-based and face-to-face social norms interventions reduced drinking-related problems among college students. Community evidence-based intervention programs reduced drinking and related problems in early adolescence.

Campus-wide Internet educational interventions have produced short-term drinking and alcohol problem reductions in college freshmen. Several new studies indicate that multicomponent college/community and military/community interventions emphasizing environmental policy can reduce alcohol-related harms among underage college students.

Nonetheless, continued research is needed in all these areas, particularly minimally studied areas (e.g., prospective studies of alcohol and the developing brain; policy studies of use/lose laws, internal possession laws, and social host liability laws; elimination of drinking-age exceptions allowing parental alcohol provision to their own children; and family parent interventions). Whether combining multiple interventions will be more effective than individual interventions warrants research attention, as does identifying which combination of interventions yields the greatest reductions with the least cost. Also, whether certain interventions are more likely to have carry-over benefits into adult life is a high research priority.

Also, while traffic deaths have declined, poisoning/overdose deaths have increased dramatically with the total reaching 39,000 in 2010. The rate of alcohol in these deaths may be underestimated. Half of the 1.6 million hospitalizations annually for overdoses involve alcohol either alone or in combination with other drugs. Alcohol impairs judgment, prompting people to take heavier doses of alcohol and drugs. It may pharmacologically potentiate effects of some drugs, particularly narcotics and pain killers, and people can overdose at lower blood alcohol levels if other drugs have been consumed. Research on alcohol/drug interactions in relation to traffic crashes and overdoses and prevention of those outcomes is a high research priority.

Much attention has been given recently to the prevention of underage drinking and on the transition from early drinking to high risk drinking to the development of alcohol use disorders. Many of the prevention initiatives developed in this regard have focused on school-based or college-based strategies for encouraging prevention. Less often examined are interventions that can be implemented in non-college settings.

Alcohol consumption during pregnancy has a broad spectrum of deleterious effects on the developing fetus. Effort is needed to develop interventions to prevent fetal alcohol exposure, improve the tools available for diagnosing fetal alcohol spectrum disorders (FASD) more accurately, and broadening our understanding of the mechanisms involved in FASD pathogenesis.

A continuing unresolved need in prevention is to show that preventive strategies known to be effective in the overall population also are appropriate and effective among minority populations and other disparities groups.

NIAAA is interested in innovative research in these domains.

Areas of investigation under this Funding Opportunity Announcement (FOA) could include, but are not limited to, studies that:

Explore factors that influence transitions in and out of excessive drinking patterns across the lifespan in the context of health risk.
Advance the epidemiology of underage drinking and examine the factors that contribute to excessive alcohol use and risk for alcohol use disorders.
Conduct secondary data analyses to understand the impact of alcohol use on chronic diseases and the factors that may interact with alcohol to modify chronic disease risk.
Improve understanding of the individual and combined influence of genetic, biological, and behavioral factors and social context on the development of alcohol use disorders and other comorbid disorders.
Improve the targeting of prevention efforts by identifying individuals at highest risk for alcohol use disorders based on current understanding of biological and environmental mechanisms underlying alcohol use initiation and progression.
Undertake studies of alcohol policies, especially pertaining to underage drinking (e.g., social host liability and keg registration) and healthcare reimbursement to determine their effects on levels of alcohol-related harms and related tobacco and drug use combined with alcohol.
Improve understanding of the implications of heavy on-line social networking and social media involvement for underage drinking patterns and drinking-related behaviors and problems.
Propose development and adaptation of social media-based interventions aimed at preventing underage drinking and related problems.
Develop strategies appropriate for the needs and alcohol-related problems experienced by the elderly.
Identify effective prevention interventions that can be implemented nationwide to reduce pregnancy, underage drinking, binge drinking, extreme binge drinking, repetitive harmful drinking that may lead to repeat driving under the influence, harms to others from these drinking patterns.
Assess the effectiveness of programs to reduce drinking during pregnancy and the risk of fetal alcohol spectrum disorders (FASD).
Encourage preventive interventions designed to reduce or eliminate such disparities by minority and health disparities populations.
Encourage culturally and developmentally appropriate screening, assessment, and intervention, including brief interventions. Assess effectiveness of prevention efforts for persons with genetic variants known to predispose people to alcohol use disorders.
Develop and test models using systems science approaches, such as agent-based system dynamics, network, or dynamic micro simulation models, to advance understanding of health-related behaviors and outcomes.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
Award Project Period	The award project period may not exceed 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Governments

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

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
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.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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

SF424(R&R) Cover