Department of Health and Human Services

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

Alcohol Use Disorders: Treatment, Services, and Recovery Research (R03)

Activity Code

R03 Small Grant Program

Announcement Type

Reissue of PA-10-101

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • April 24, 2014 - See Notice NOT-AA-14-010. Notice to Clarify the Scope.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PA-13-162

Companion Funding Opportunity

PA-13-160, R01 Research Project Grant;

PA-13-161, R21 Exploratory/Developmental Research Grant Award

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 grant applications from institutions/organizations that propose to support  research on behavioral and pharmacological treatment for alcohol use disorders; organizational, financial, and management factors that facilitate or inhibit the delivery of services for alcohol use disorders; and phenomenon of recovery from alcohol use disorders.  

Key Dates
Posted Date

March 28, 2013

Open Date (Earliest Submission Date)

May 16, 2013

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.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

May 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites applications to support research on various topics in the field of alcohol treatment and services for alcohol use disorders.  This funding initiative (R03) supports small research projects that can be carried out in a short period of time with limited resources including pilot and feasibility studies, secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The scope of interest is wide-ranging. It includes pharmacologic and behavioral treatments; recovery strategies; interventions for alcohol-induced tissue damage; and the organizational, financial, management, and environmental factors that facilitate or inhibit the delivery of evidence-based services for alcohol use disorders.

Research objectives of this FOA include, but are not limited to, research within the following four broad research domains: (1) medications development for the treatment of alcohol use disorders and alcohol-induced tissue damage; (2) behavioral therapies and mechanisms of behavioral change; (3) health services research; and (4) recovery research. Cutting across these domains, NIAAA encourages treatment and health services-related studies on a number of special emphasis populations and topics including: (a) psychiatric/substance abuse/medical comorbidity, (b) adolescents, (c) fetal alcohol spectrum disorders, (d) health disparities/special populations, and (e) use of novel methods and technologies.

BROAD RESEARCH DOMAINS

1. Medications Development for the Treatment of Alcohol Use Disorders and Alcohol-Induced Tissue Damage

Efforts to develop medications for alcohol use disorders have expanded rapidly in recent years. Three agents—disulfiram, naltrexone, and acamprosate—are now approved for use in the United States and many other countries. Recently, topiramate also has been shown to be effective in treating alcohol-dependent patients. However, because of the heterogeneous nature of alcohol use disorders, many patients have limited or no response to these medications. Therefore, developing new medications and evaluating their use in combination with other medications and with behavioral therapies are important steps toward improving treatment outcomes for all individuals with alcohol use disorders. A variety of new compounds are being investigated in clinical trials, including gabapentin, ondasentron, levetiracetam, quetiapine, baclofen, zonisamide, pregabalin, prazosin, and kudzu.

Alcohol-seeking behavior and drinking are influenced by multiple neurotransmitters, neuromodulators, hormones, and intracellular networks. Thus, there are many potential targets for drug development. Research to date has focused on opioid, serotonin, dopamine, glutamate, and gamma-aminobutyric acid (GABA); cannabinoids, corticotrophin-releasing factor (CRF), nicotine, adenosine, and neuropeptide systems (e.g., neuropeptide Y); signal transduction pathways (e.g., protein kinase A and protein kinase C); and gene transcription factors (e.g., delta fos B and cAMP response element-binding protein [CREB]). Efforts to define different elements of addiction include reward and motivation, negative affect, cue conditioning/craving/wanting, disinhibition/impulsivity/compulsivity/habituation, memory, executive function/cognitive function, and interoception/self-awareness. It is important to identify the neurocircuits underlying these elements and investigate their interactions and integration. The ultimate goal is to target specific sites in these neurocircuits with compounds that modulate them.

Advances also have been made in understanding the mechanisms of alcohol-induced tissue damage. Oxidative stress and inflammation play a major role in the pathogenesis of alcohol-associated injuries of various organs, including the liver, pancreas, heart, lungs, brain, and peripheral nervous system. Potential therapeutic agents include those that attenuate the actions of pro-inflammatory cytokines (e.g., the tumor necrosis factor (TNF)-a), and antioxidants (e.g., S-adenosyl-L-methionine (SAMe), glutathione, and vitamins A and E). Other potential new treatments of alcoholic liver disease include cannabinoid CB1 antagonists and CB2 agonists, metformin (an insulin-sensitizing agent), antifibrotic agents, prebiotics, probiotics, and zinc.

Finally, to improve safety, efficacy, and efficiency of medications, it is important to identify and characterize patients who respond positively to the medications and those who experience adverse events. Progress in personalized medicine includes evaluating polymorphisms of the mu opioid gene, such as A118G, which appears to modify responses to naltrexone, and the L versus S allele on the serotonin transporter gene, which may influence responses to ondansetron. These and similar discoveries may someday enable clinicians to tailor treatment to the biological profile of individual patients, and thereby to achieve better treatment outcomes.

Specific areas of research include, but are not limited to, the following examples:

2. Behavioral Therapies and Mechanisms of Behavioral Change  

Over the past 20 years, research on the behavioral treatment of alcohol use disorders has progressed substantially. Behavioral interventions that have demonstrated efficacy include motivational enhancement therapy, cognitive behavioral therapy, brief interventions, behavioral couples therapy, twelve-step facilitation therapy, and the community reinforcement approach. Interestingly, several studies have suggested that these behavioral therapies appear to have similar efficacies when compared with standard treatments. Currently, very little information is available on how and why these behavioral treatments are effective. Understanding the underlying mechanisms of action of an intervention involves identifying the active processes and their specific effects on diverse patient groups, including racial/ethnic minority, rural, and low-income populations. Because many individuals with alcohol use disorders change their drinking behavior without help from addiction treatment providers or self-help groups, it is as vital to understand how and why people change their drinking outside of specialized treatment settings as it is within them.

Toward this goal of understanding the mechanisms of behavioral change, new transdisciplinary, multilevel, and collaborative approaches are needed that integrate multiple domains of knowledge , including cognitive, affective, and social neuroscience; neuroimaging; genomics; proteomics and metabolomics; social psychology; economics; and computational science. Progress in this complex and challenging area of treatment research will represent a major milestone for the alcohol treatment community. 

Specific areas of research include, but are not limited to, the following examples:

Behavioral Therapies

Mechanisms of Behavioral Change

3.  Health Services Research

Based on data from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC), a national survey of the non-institutionalized population in the United States, it has become clear that the U.S. population is characterized by a continuum of drinking types, ranging from low-risk drinkers to high-risk and chronic, relapsing alcohol-dependent drinkers. Approximately 65 percent (144 million) of adult Americans drank alcohol at various times during the past year. Of those, 59 million Americans exceeded high-risk drinking limits and 18 million of these had a diagnosis of alcohol use disorders. Only an estimated 13 percent of people identified as alcohol dependent had ever received specialty alcohol treatment. Epidemiological data such as these demonstrate the need to broaden and enhance the continuum of health care for alcohol-related problems and disorders. The menu of alcohol services, and the organizations that deliver them, needs to be diversified, enhanced, extended, and provided in a range of settings that meet the needs of underserved groups needing interventions tailored to their specific alcohol-related issues. Treatments that are attractive, affordable, accessible, and effective for different types of drinkers need to be identified, tested, and adopted. For example, stepped care would be appropriate for reducing binge drinking in a college population, whereas collaborative care models that integrate treatments for addiction and co-occurring conditions in primary care would be more appropriate for alcohol-dependent individuals with co-occurring medical and/or psychiatric conditions.

These research challenges provide many exciting opportunities for advancing services research. Barriers to treatment must be identified and effective strategies developed to offset these barriers in a variety of settings, including specialty addiction settings,  general medical settings (e.g., primary care and mental health care), and settings outside the medical sector (e.g., the workplace and criminal justice, social welfare, and school systems). At a minimum, services should include screening, brief intervention, and referral, if needed. New approaches to establishing more effective evidence-based practices include adaptive models personalized to subtypes of drinkers,  long-term management of chronic alcohol dependence, concurrent management of multiple comorbidities, and the patient-centered medical home model. These and other innovative health care approaches need to be adapted and tested for application in real-world practice settings.

Comparative effectiveness studies are encouraged as a tool for identifying the most effective and cost-effective evidence-based interventions. For example, comparing two or more pharmacological and/or behavioral therapies in the same study can be insightful in determining the better choice in certain populations and settings. In the end, this will make the treatment process more efficient and less costly. Also needed is treatment outcome research that identifies, evaluates, and tests long-term outcome measures in clinical effectiveness trials. This research should focus on how best to measure outcomes including drinking outcomes, quality of life, and alcohol-related consequences as well as measures of treatment quality and process from a multidisciplinary perspective. Applicants are also encouraged to discover and derive robust outcome measures from archival, policy, and other secondary data.

A recent review of the NIAAA health services research portfolio revealed a decade of significant advances in critical research areas while at the same time highlighting several important research gaps. As a result of the review and current trends in research on alcohol-related treatment, NIAAA encourages research from among the following five priority areas: implementation science, disease management, access to care, health disparities, and health economics.

Specific areas of research include, but are not limited to, the following examples:

 Implementation Science

Disease Management

Access to Care

Health Disparities

Health Economics

4.  Recovery Research

The term recovery refers to the disappearance of the signs and symptoms of alcohol use disorder accompanied by a state of well-being following an episode of alcohol use disorder. Research indicates that there is a substantial level of recovery from alcohol dependence. Twenty years after the onset of alcohol dependence, about three-fourths of individuals are no longer dependent. Moreover, more than half of those individuals drink at low-risk levels without symptoms of alcohol dependence.

Approximately 75 percent of persons who recover from alcohol dependence do so without seeking any kind of help, including specialty alcohol programs and Alcoholics Anonymous (AA). Recovery outside of treatment is more likely in those with fewer symptoms of dependence and fewer comorbid psychiatric disorders. Notwithstanding the high rates of natural recovery from alcohol dependence, in most cases, it is a chronic relapsing illness with serious, often devastating psychological, medical, and social consequences for affected individuals and families over time. In many cases, whether or not affected individuals ever seek treatment, the adverse consequences of alcoholism extend well beyond the period of dependent drinking and may even span multiple generations.

What causes change in drinking behavior that leads to recovery? Because most individuals recover without treatment, it is important to study natural recovery by evaluating mediators and moderators of drinking behavior in subtypes of alcohol users. Biological, psychological, and contextual factors should be considered, including, but not limited to, cultural and socioeconomic milieu, lifestyle, endophenotypes, cognitive functioning, and sleep and other medical disorders.

Specific areas of research include, but are not limited to, the following examples:

SPECIAL-EMPHASIS POPULATIONS AND TOPICS

A)  Treatment for Psychiatric/Substance Abuse/Medical Comorbidity

Alcohol-dependent individuals have exceptionally high rates of co-occurring psychiatric disorders. According to NESARC data, for example, alcohol-dependent individuals, as compared with non-alcohol-dependent individuals, are about four times more likely to have a mood disorder, three times more likely to have an anxiety disorder, seven times more likely to have an antisocial personality disorder, six times more likely to be nicotine dependent, and over thirty times more likely to be dependent on other drugs. Approximately half of individuals with schizophrenia suffer from an alcohol and/or substance use disorder. Similarly, 46 percent of those with bipolar disorder also have an alcohol use disorder. Moreover, in alcohol treatment populations, risk and prevalence rates of co-occurring psychiatric and substance use disorders are often much higher than those observed in the general population. For example, the rate of tobacco use among alcohol-dependent individuals seeking alcohol treatment is approximately 80 percent compared with 26 percent among non-dependent individuals in the general population. In addition, a significant number of alcohol-dependent individuals exhibit two or more comorbidities. Although individuals with comorbid alcohol dependence and psychiatric disorders are most likely to seek treatment, they have a poorer treatment prognosis, a higher risk for treatment dropout, less support for sobriety from family and the work environment, and a higher risk for suicide.

In addition to psychiatric and substance abuse comorbidities, a significant number of alcohol-dependent patients have comorbid medical disorders. For example, in the United States, approximately 20 percent of patients in treatment for HIV have been diagnosed with current co-occurring alcohol use disorders. Rates are even higher for a diagnosis of lifetime alcohol use disorders, with estimates of 26 to 60 percent in people living with HIV/AIDS as compared with 14 to 24 percent in the general population. Recent studies suggest that problematic drinking worsens the clinical course of HIV/AIDS. In addition, over 4 million Americans are living with hepatitis C infection. High-risk drinking also has been associated with hepatitis C, and like HIV/AIDS, drinking may accelerate the progression of this disease. Often HIV/AIDS and hepatitis C are co-occurring conditions that complicate the long-term treatment of this population.

Research on effective strategies to treat alcohol comorbidity is still in its early stages. The appropriate treatment strategy depends on the type and severity of the comorbidity as well as population subtypes within a comorbid population. 

Specific areas of research include, but are not limited to, the following examples:

B)  Treatment for Adolescents

Alcohol use remains a pervasive problem for adolescents in the United States, resulting in adverse and sometimes serious consequences. Approximately 12 percent of 12-year-olds, 30 percent of 14-year-olds, 60 percent of 16-year-olds, and over 70 percent of 18-year-olds consumed alcohol. Across all adolescents groups, there are approximately 7.2 million binge drinkers, 2.3 million heavy drinkers, and 1.5 million with alcohol use disorders. Most adolescents in treatment for alcohol and/or drug problems relapse after 6 months of conventional treatment. Researchers have begun to test a variety of behavioral therapies, including cognitive behavioral therapy, family-based interventions, multisystemic therapy, and motivational enhancement therapy. So far, only a few medications studies have been conducted in this population.

Research on adolescent treatment is still in early stages. To design more effective treatments, it is important to develop a multidisciplinary approach that integrates biological, psychological, and social factors across different stages of development. Furthermore, future research needs to focus on subgroups of adolescents, including those with a range of alcohol severities, different comorbidities, racial ethnic groups, and cultural differences. Studies also should evaluate different settings, including rural, community, schools, unemployment programs, and the juvenile justice system.

Specific areas of research include, but are not limited to, the following examples:

C)  Treatment for Fetal Alcohol Spectrum Disorders (FASD)

The FASD “umbrella” encompasses an array of health consequences of prenatal alcohol exposure including birth defects and neurological abnormalities in children whose mothers consumed alcohol during pregnancy. Fetal alcohol syndrome (FAS), a condition at the most severe end of the FASD spectrum, is characterized by facial dysmorphology, growth retardation, and brain damage, resulting in cognitive and behavioral impairments. Today, FAS remains the leading known preventable cause of mental retardation and other neurobehavioral disabilities. It is estimated that 1 to 2 per 1,000 live births in the United States have FAS, and the incidence of all FASD is on the order of 1 per 100 live births. A host of secondary impairments stem from the behavioral deficits of those with FASD. Their characteristic poor judgment, faulty social skills, and failure to learn from experience commonly lead to complications, such as substance use, arrest/incarceration, failure in school, economic problems, unemployment, and psychiatric comorbidities. Sadly, FASD is frequently not recognized or treated. A major research effort is needed to improve the identification and treatment of children and adults with FASD.

Specific areas of research include, but are not limited to, the following examples:

D) Treatment for Health Disparities/Special Populations

NIAAA seeks to elucidate the importance of alcohol treatment, service delivery, and recovery research among racial/ethnic groups and rural and low-income populations. In addition to these populations already experiencing health disparities in the United States, the recent immigration of large numbers of people from diverse cultures requires examination of existing treatment methods for relevance, efficacy, and effectiveness across all levels of adaptation/acculturation. Other subgroups with specific needs that often are understudied include: youths ages 18 to 25 not attending college; youths in the juvenile justice system and/or foster care; adults over the age of 65; youths and adults living in rural or other areas where treatment access is difficult; women residing in shelters for victims of domestic violence; the unemployed; minorities (e.g.,  Native Americans, African Americans, Hispanic Americans, and Asian American/Pacific Islanders); and adolescents and adults with developmental disabilities due to prenatal alcohol exposure. Of particular interest is comparative effectiveness research in special populations.

Military personnel, veterans, and their families are also an NIAAA priority. In particular, NIAAA seeks research on the development of effective alcohol screening instruments and treatments for this population. Comparative effectiveness research to compare the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor harmful drinking and alcohol use disorders is needed in military settings and in veterans and military family environments. Treatment research should address a variety of comorbid conditions commonly found in this population, including posttraumatic stress disorder (PTSD), traumatic brain injury, depression, anxiety, sleep disturbances, and chronic pain. Of particular interest is research related to individuals who are serving or have served in Operation Enduring Freedom (Afghanistan) and Operation Iraqi Freedom (Iraq). In addition, research related to all phases of the deployment cycle (e.g., pre-deployment, deployment, reintegration, and separation) for all branches of the military and veterans is of interest. National Guard and Reserve service members, Individual Augmentees, and families have been identified as special needs populations that are of particular interest due to limitations in support related to not being attached to a military installation.

Specific areas of research include, but are not limited to, the following examples:

E) Use of Novel Methods and Technologies

Within the last decade, a number of novel methods and technologies have been developed to speed the course of alcohol treatment and related research. For instance, the widespread availability of the Internet, wireless technology, and computers has made possible a number of technological advances that capture important real-time information from patients in the field; synthesize, simulate, and statistically model large quantities of data in efficient and clinically meaningful ways; and deliver interactive computerized versions of promising behavioral interventions.

With the tremendous promise potentially afforded by these tools, research and development is continually evolving. More research is needed to further develop, refine, validate, and creatively implement these novel methods within alcohol clinical trials and treatment paradigms.

Specific areas of research include, but are not limited to, the following examples:

Technological Methods

Statistical Methods

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

Direct costs of up to $50,000 per year may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).

Award Project Period

The maximum project period is 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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Letter

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

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

·         No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

Foreign Institutions

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

3. Submission Dates and Times

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

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?     

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

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

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Daniel Falk, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Phone: (301) 443-0788
Email: falkde@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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