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.

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

This announcement provides support for (a) analyzing previously collected data in order to address key issues that have emerged from recent findings in alcohol epidemiology and prevention research, or (b) developing new analytic techniques for conducting studies in alcohol epidemiology and prevention research.

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. 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

Epidemiologic research projects typically generate data with potential utility beyond the specific hypotheses and questions that they were designed to address. In addition, the general progress of the field often uncovers new questions which could be, in part or in whole, addressed through the application of data originally gathered from previous projects and for other purposes. Furthermore, given the expense of original data collection and the constrained national budget for research support, making use of existing data to answer new and emerging questions is a sensible use of scientific resources. Sections of the announcement below highlight areas where emerging scientific questions in the alcohol field seem especially amenable to fruitful analyses using existing data. At the same time, the development of new analytic techniques and statistical methods for alcohol research typically employs existing data sets to refine these methodological advances. This announcement also encourages the development of such techniques, approaches, models, and measurement systems through research that employs data that are already available. Below are highlighted some technical developments of interest to the field that could be advanced using existing data.

Applicants interested in either approach should consider the wide range of existing data sources that are available in the alcohol field. These include the National Longitudinal Alcohol Epidemiologic Survey (NLAES); the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) conducted by NIAAA; the National Longitudinal Survey of Youth (NLSY) conducted by the U.S. Department of Labor; the National Adolescent Student Health Survey (NASHS), a cooperative project of the U.S. Department of Health and Human Services, Public Health Service, Office of Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, and the National Institute on Drug Abuse; the National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics (NCHS); the National Health Interview Survey (NHIS) conducted by NCHS; the National Survey on Drug Use and Health (NSDUH) (formerly the National Household Survey on Drug Abuse (NHSDA) and National Survey of Substance Abuse Treatment Services (N-SSATS), conducted by the Substance Abuse and Mental Health Services Administration; and the National Mortality Follow-back Survey conducted by NCHS. Non-survey data resources include Fatality Analysis Reporting System (FARS), a nationwide census collected by National Highway Traffic Safety Administration(NHTSA) that provides public yearly data regarding fatal injuries suffered in motor vehicle traffic crashes; The Uniform Crime Reporting (UCR) Program, collected by FBI; National Emergency Medical Services Information System (NEMSIS), a cooperative project of NHTSA and the Health Resources and Services Administration (HRSA) that is designed to provide a uniform national emergency medical services dataset, with standard terms, definitions, and values, as well as a national EMS database, with aggregated data from all states on a limited number of data elements. Applicants may also secure access to other data sets that may or may not be in the public domain, such as those collected under research grant funds, sponsored by private entities (e.g., philanthropic foundations, motor vehicle administrations, or commercial businesses) or originally collected for purposes other than research (e.g., health care, criminal justice or insurance data).

One way of exploring available public data offerings is to consult the Alcohol Epidemiology Data Directory. This directory is compiled by NIAAA's Alcohol Epidemiologic Data System and is a compendium of existing public data resources available in the alcohol epidemiology field. It is available on NIAAA's website at: http://pubs.niaaa.nih.gov/publications/datasys.htm or from an NIAAA contractor: CSR, Incorporated, 2107 Wilson Boulevard, Suite 1000, Arlington, VA 22201, 703-312-5220 (Tel), 703-312-5230 (Fax), [email protected].

Methodology Development

Single or multiple data sets may be used to develop new or improved research designs, measurement techniques, or analytic approaches. For example, researchers may wish to develop new analytic techniques for longitudinal designs that take into account transitions in alcohol and other drug use behaviors over time, or use existing data to undertake the simulation of complex systems for predicting the use of alcohol or the emergence of alcohol-related problems at an individual, group, or community level. Appropriate approaches for this announcement include methodologies that help develop accurate measurement of alcohol exposure, risk relationship and outcomes of alcohol consumption, or advance understanding of the causes, development, consequences of alcohol use and therefore provide information for forming efficient treatment as well as prevention approaches. Examples of methodology research that are encouraged include:

• & Spatial statistical methodologies that advance knowledge on alcohol and related outcomes in geographic context
• & Statistical methodologies for alcohol longitudinal studies of life-cycle effects and processes
• & Statistical models that describe and predict individual-level alcohol consumption patterns and related factors and processes across various timeframes
• & Systems science methodologies (i.e., systems-based simulation modeling methods), such as agent-based, network, system dynamics, and microsimulation modeling, that examine the simultaneous effects of alcohol related behaviors or interventions on multiple outcomes of interest as well as the mechanisms underlying such relationships
• & Analytical approaches for real-time assessment of alcohol consumption and related behaviors, such as through the use of ecological momentary assessment (EMA), mobile, or sensor technologies
• & Effective measurement of alcohol consumption for children and adolescents that is developmentally appropriate. Such measurement will help define age-appropriate levels of alcohol involvement and improve understanding of impact of alcohol use on children and adolescents

Gene by Environment Research

Many studies have sought to determine how environmental exposures moderate heritable behavioral traits and outcomes, such as excessive alcohol use. NIAAA encourages research to further advance understanding of etiological mechanisms through which environments and genes contribute to individual- and population-level differences in alcohol use initiation, escalation and progression toward alcohol dependence and associated problems. Environmental effects may include broad social structures (macro environment), such as urban or rural residence, level of residential stability or local alcohol policies; or more proximal, situational effects, such as familial and peer networks, norms exhibiting social constraints on drinking behaviors, or targeted intervention components (micro environment). The influence of multiple genes on a range of individual-level factors may interact with environments (GxE interaction) to produce alcohol-related outcomes. New knowledge can be gained in part from utilizing data harmonization and systematic pattern recognition in secondary analyses powered by combined large and small datasets across current and previously-funded studies. The examination of sources of influence on harmful patterns of alcohol use within and across multiple domains and levels of environment is critical to development of targeted preventive and therapeutic interventions.

New approaches are needed to examine the complex effects of varied combinations of episodic and cumulative clusters of experiential events exerted on individual behavioral choices that vary from individual to individual across progressive stages of development. These approaches are potentially advantageous for exploring alcohol-related behavioral and environmental exposure phenotypes, and biological endophenotype markers, as well as epigenetic influences on risks for alcohol use disorders. New methods and research designs ultimately can enhance future GxE replication by linking data and fostering collaborations across investigators and scientific disciplines. A variety of approaches for examining gene-environment interplay in analyses of existing data may include, but not be limited to the following:

• & Use or development of a common metric of alcohol-related phenotypic and environmental measures across study designs
• & Use of spatial analysis techniques to enhance the specificity of exposure measures, especially as individuals move across time through different levels of micro- and macro-environments
• & Use of novel statistical or systems-based computational modeling techniques when pooling and harmonizing measures across independent small and large longitudinal studies
• & Choosing genetically informative designs that help to overcome methodological challenges in GxE studies such as: scale of measurement, type I errors, non-replication, inadequate power, and population stratification
• & Appropriate choice of genome-wide, hypothesis-free approaches to identify risk genes and integration of biologically plausible measures into theoretical models of vulnerability and AUD trajectories
• & As appropriate, selection of validated functional genetic variants or variants implicated in GWA or deep sequencing studies

Fetal Alcohol Spectrum Disorders

Prenatal alcohol exposure is the leading preventable cause of birth defects in the U.S. Fetal alcohol spectrum disorders (FASD) can occur following prenatal alcohol exposure resulting in a distinctive set of anthropometric and central nervous system abnormalities across a continuum of severity, ranging from mild to moderate cognitive and growth deficiencies to severe mental retardation. Studies examining risk factors for and effects of FASD have estimated the overall prevalence of fetal alcohol syndrome (FAS the most severe end of the FASD continuum) in the U.S. to range from 0.5-2.0 cases per 1000 births. In addition, rates as high as 9 per 1000 births reported in some select U.S. communities at highest risk for heavy drinking among pregnant women; and much higher rates have been reported for some high-risk communities in South Africa, Russia, and Italy. Cumulative costs of care for all FAS-affected individuals in the US have been estimated at up to $6 billion annually. Reports from prenatal clinics and postnatal studies suggest that 20 to 30 percent of women drink at some time during pregnancy. To date, the primary focus of many FASD studies in high-risk communities has been to gain an understanding of FASD risk factors and to implement prevention and treatment. Whereas most cases of FAS have been diagnosed in children of heavily drinking mothers, the precise quantity and frequency of alcohol consumption and timing of gestational exposure required to produce abnormalities is unknown. Since drinking during pregnancy is considered 100 percent preventable, FAS has been reported to be the most preventable cause of mental retardation.

Variable rates in high-risk populations across global regions reflect varied cultural norms in drinking. A number of maternal risk factors have been identified to place offspring at risk for FASD, including, moderate to heavy maternal alcohol consumption prior to, during and after pregnancy, poor prenatal care and nutrition, family history of heavy drinking, multiple pregnancies, and low socioeconomic status. Though much has been published on diagnostic criteria for FASD in specific high-risk, heavily drinking populations, more research on the full range of drinking patterns resulting in prenatal alcohol exposure across gestational periods, as well as the etiology of neurodevelopmental effects across the lifespan of prenatally affected individuals is desired. In addition, understanding the importance of dysmorphic changes in prenatally exposed individuals compared to timing and severity of exposure can help inform health services delivery. NIAAA encourages secondary analysis of FASD data from clinic-based assessments, epidemiologic and observational studies, and prevention and treatment studies, including but not limited to attention on the following:

• & Effects of timing of exposure in humans (cumulative versus peak dosage) as well as periods of gestational exposure on a range of offspring disabilities from infancy to adulthood
• & Prospective associations between maternal drinking patterns and conduct disorder or other externalizing problems among prenatally exposed offspring from adolescence through young adulthood
• & Influence of exposures to co-occurring prenatal alcohol and other substance use or life stressors
• & Examination of a range of severity of alcohol exposure data combined across clinical studies to establish reliable and plausible thresholds to distinguish research-based diagnostic criteria from rapid screening criteria used in routine clinical practice
• & Rates of adoption by primary or OB-GYN providers of screening, brief intervention or other alcohol use assessments or message delivery practices to women of childbearing age or pregnant women
• & Validation of diagnostic codes, such as DSM-V Alcohol-Related Neurodevelopmental Disorder (ND-PAE) diagnostic criteria or ICD-9-CM/ICD-10-CM medical coding classifications for Fetal Alcohol syndrome (dysmorphic)
• & Patterns of risky drinking among prenatally exposed adolescents and emerging adults
• & Examination of effects of appropriate medical and developmental interventions for FASD-affected individuals, their parents and teachers on development of adverse lifestyle outcomes
• & Epigenetic effects of prenatal alcohol exposure

Chronic Diseases and Conditions Related to Alcohol Use
Alcohol consumption has been linked to many chronic diseases and conditions. According to the International Classification of Disease (ICD)-10, twenty-five chronic diseases and conditions are entirely attributable to alcohol. Alcohol use also increases the risk of certain cancers, neuropsychiatric conditions, and numerous cardiovascular and digestive diseases. Alcohol use can be a risk factor that not only affects the onset of various chronic diseases but also exacerbates the ongoing extent and severity of those diseases. There is a need for studies of the effects of heavy drinking on chronic disease outcomes. Many existing datasets include limited numbers of heavy drinkers. Combined datasets could overcome this obstacle enabling examination of understudied populations and rare outcomes. Examples of research topics are:

• & Effects of heavy drinking on the development of cardiovascular disease and diabetes (less is known about heavy drinking than the putative beneficial effects of moderate drinking because sample sizes of heavy drinkers tend to be small)
• & Effects of moderate and heavy drinking among cancer survivors (there has been little research and this is a group that may be willing to modify their drinking habits) studies could exam prevalence and outcomes including cancer recurrence, changes in drinking patterns pre-post diagnosis

Other Topics

Applications proposing to use existing data to achieve progress in other areas of alcohol epidemiology and prevention research are also encouraged under the terms of this announcement. Applicants may also use secondary analyses to address emergent research questions in College Drinking, Health Disparities, Public Policy Impacts, Screening and Brief Intervention, and Longitudinal Trajectories of Drinking Behavior.

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.

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)

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.

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.

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.

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

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept 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.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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.

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

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

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

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

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

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

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

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

Research Strategy: Investigators are encouraged to specify the extent to which anticipated study results can help to inform future advances in prevention and clinical research. Also inclusion of a strong justification is encouraged for the choice of study design and methodological or analytical strategy, as well as the selection of candidate environments or genes.

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, with the following modification:

• & All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

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.

This initiative is not subject to intergovernmental review.

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.

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.

Applicants are required to follow our Post Submission Application Materials policy.

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

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.

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.

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).

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 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?

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?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves 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.

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.

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.

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

As part of the scientific peer review, all applications:

• & May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• & Will receive a written critique.

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

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

• & Scientific and technical merit of the proposed project as determined by scientific peer review.
• & Availability of funds.
• & Relevance of the proposed project to program priorities.

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.

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.

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

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.

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

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Wenxing Zha, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0633
Email: [email protected]

For Research on FASD or GxE:

Marcia S. Scott, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-6328
Email: [email protected]

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

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

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.

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.