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)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Research on Alcohol-Related Public Policies such as Those Detailed in the Alcohol Policy Information System (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PA-07-428

Related Notices

  • April 11, 2014 - See Notice NOT-AA-14-007. Notice to Extend the Expiration Date.
  • 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-11-089

Companion FOA

PA-11-087, R01 Research Project Grant
PA-11-088, R03 Small Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.273 

FOA Purpose

This Funding Opportunity Announcement (FOA) invites applications to conduct research on the effects of alcohol-related public policies on health, economic, and social behaviors and outcomes. The purpose of the FOA is to advance understanding of public policy pertaining to alcohol as a tool for improving public health and welfare. The NIAAA has developed the Alcohol Policy Information System (APIS) as a resource for researchers conducting studies in this area; studies that make use of the information available through APIS are particularly encouraged. Research supported by this FOA includes, but is not necessarily limited to, studies examining the effects of alcohol-related public policies on health-related behaviors and outcomes, evaluations of public policies as tools for improving public health, and research to advance methods and measurement used in studying relationships between alcohol-related public policies and health-related behaviors and outcomes.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

January 16, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard 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(s)

Standard dates apply

Expiration Date

(Extended to September 8, 2014 per NOT-AA-14-007), Originally May 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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 conduct research on the effects of alcohol-related public policies on health, economic, and social behaviors and outcomes. The purpose of the FOA is to advance understanding of public policy pertaining to alcohol as a tool for improving public health and welfare. The NIAAA has developed the Alcohol Policy Information System (APIS) as a resource for researchers conducting studies in this area; studies that make use of the information available through APIS are particularly encouraged. Research supported by this FOA includes, but is not necessarily limited to, studies examining the effects of alcohol-related public policies on health-related behaviors and outcomes, evaluations of public policies as tools for improving public health, and research to advance methods and measurement used in studying relationships between alcohol-related public policies and health-related behaviors and outcomes.

Research Objectives

The NIAAA seeks to expand knowledge about the effects of alcohol-related public policies on health, economic, and social behaviors and outcomes. Such knowledge can inform discussions and decisions about public policies that ultimately may lead to improvements in public health and welfare. The specific objectives of this FOA are to provide support for (a) studies of the effects of alcohol-related public policies on specific health, economic, or social behaviors and outcomes; (b) evaluations of policy measures as means of improving health outcomes; (c) analyses to elucidate the behavioral linkages through which alcohol-related policies affect intervening attitudes or behaviors that ultimately affect health-related behavior or outcomes; and (d) research to advance methods and measurement used in studying relationships between alcohol-related public policies and health-related behaviors and outcomes. Studies that make use of policy information provided in NIAAA's Alcohol Policy Information System (http://alcoholpolicy.niaaa.nih.gov) are particularly encouraged. Grants under this announcement are not intended as a means for promoting enactment, adoption, or repeal of any specific public policies.

Background

The adverse consequences of alcohol consumption on health, social, and economic outcomes are large in magnitude and diverse in character. These effects encompass a wide variety of health conditions, both chronic and acute, as well as effects on development and maturation, educational achievement, employment, productivity, violent and criminal behavior, health care utilization, cultural mores, and family and interpersonal relations. A substantial scientific literature has identified several alcohol-related policy measures, including maximum allowable blood alcohol levels for drivers, minimum legal drinking ages, alcoholic beverage taxes, and other policies that influence access to alcohol, that can lead to significant improvements in some outcomes. However, governments at all levels have established a large and varied body of public policy addressing myriad aspects of alcoholic beverage manufacture, packaging, distribution, pricing, advertising, marketing, sales, and consumption, as well as post-consumption behavior and delivery of, access to, and financing of health care services for treatment of alcohol use disorders and the medical consequences of alcohol consumption. Such policies have the potential to affect a wide variety of health, social, and economic outcomes.

For most policy measures, there is little or no research assessing their effects on particular outcomes or their effectiveness in achieving any specific objectives. Even for relatively well-studied policies such as excise taxes, empirical findings exhibit substantial variation. Disparities in findings due to factors such as measurement problems, confounding, and complex behavioral linkages can leave significant uncertainty about the true magnitudes of policy effects on specific outcomes and behaviors of interest. As a result, policy debates and decisions often must proceed without the benefit of clear, research-based knowledge of the health, social, and economic consequences of specific policy choices.

Despite limited scientific evidence about the effects of many policies, findings from policy studies to date suggest that policy tools have the potential to generate improvements in public health on a scale unmatched by other approaches to alleviating the adverse consequences of alcohol consumption. For example, substantial evidence indicates that public policies, including tighter restrictions on blood alcohol levels permitted for drivers and minimum drinking age laws, have played a signal role in the 50-percent decline in the rate of alcohol-related traffic crash fatalities per population in the United States over the twenty-five-year period beginning in 1980. This decline represents a total of approximately 150,000 deaths averted. However, these changes occurred over a period that included many other economic, social, and cultural changes. The challenge of discerning how any particular policy might have influenced specific outcomes of interest in the presence of numerous confounding factors is one of the main challenges of policy research. This FOA seeks to encourage studies that address these difficulties as well as studies that advance the methodologies available for conducting such analyses.

Areas of Research Interest

A variety of research designs may be appropriate to assessing the effects of alcohol-related public policies on health, economic, and social behaviors and outcomes.  Analytic approaches that may be useful in such studies include (but are not limited to) multivariate regression analysis, econometric models, structural equation modeling, latent variable models, time-series analysis, and hazard and survival analysis.  Studies of the effects of alcohol-related public policies commonly take the form of natural experiments: secondary analyses of problem indicator data and relevant covariates observed before and after a policy change takes effect. Research designs that pool time-series and cross-sectional data often are particularly well-suited for analyzing the effects of policies on specific outcomes of interest.  Studies that use only cross-sectional data generally are more limited in the research questions that they can address, but well-controlled cross-sectional analyses can provide useful insights nonetheless, particularly in exploratory analyses.  Well-designed studies using any of these or other approaches will be based on clearly defensible theoretical foundations and employ appropriate strategies to discern the causal influences of the policy or policies in question from effects that appear to be associated with the policies but actually are attributable to other, possibly unobserved factors.

This FOA also encourages applicants to consider using a systems science approach to the study of alcohol-related policy. Systems science methodologies (i.e., systems-based simulation modeling methods) such as agent-based, network, or system dynamics modeling are well-suited to examining the complexities of real world phenomena such as alcohol-related policy. Systems science methods are complementary to those described above and are particularly useful for capturing feedback loops (bidirectional relationships), dynamic behavior (i.e., change over time), non-linear effects, and time-delayed effects.  These methods provide frameworks that can facilitate integration of extant empirical knowledge from many sources and disciplines to calibrate models that may derive from a variety of theoretical perspectives.  Of particular value is the ability of such methods to examine the simultaneous impacts of policy interventions on multiple outcomes of interest as well as the mechanisms underlying such relationships.  In addition, simulations permit “virtual experimentation”, which allows investigators to explore scenarios and interventions that could not be examined under naturalistic or experimental conditions (due to practical, legal, or ethical constraints, for example). Such in silico experimentation also conserves research resources by reducing or eliminating costs associated with human subjects recruitment and retention, permitting examination of a variety of alternative policy scenarios, and compressing the time-cycle for results. Well-designed simulation studies will use modeling approaches and theoretical frameworks that are appropriate to the particular research questions addressed and will include pre-specified strategies for assessing the validity and quality of model results.

Data on outcome variables may be obtained from various sources. Numerous survey and archival datasets are available, including some that provide detailed information on outcomes specifically relevant to alcohol, such as the National Survey on Drug Use and Health (NSDUH; http://www.oas.samhsa.gov/nhsda.htm), the Fatality Analysis Reporting System (FARS; http://www.nhtsa.dot.gov/people/ncsa/fars.html), the Behavioral Risk Factor Surveillance System (BRFSS; http://www.cdc.gov/brfss/), and the Youth Risk Behavior Surveillance System (YRBSS; http://www.cdc.gov/healthyyouth/yrbs/index.htm). Many outcomes of interest also may be measured at the aggregate level, including per capita levels of alcohol consumption, traffic crash fatality rates, measures of the incidence or prevalence of specific health conditions, and broader indicators of the burden of alcohol-related problems. Numerous data sources with data relevant to alcohol-related behaviors and outcomes are described and documented in the Alcohol Epidemiologic Data Directory developed by the NIAAA through the Alcohol Epidemiology Data System Contract; the Data Directory is available at http://pubs.niaaa.nih.gov/publications/2008DataDirectory/2008DataDirectory.htm.

Alcohol Policy Information System. Data on policies ultimately derive from the public policy documents themselves, primarily statutes and regulations. The Alcohol Policy Information System (APIS; http://alcoholpolicy.niaaa.nih.gov) is a recently-developed online data resource that provides authoritative, detailed, and comparable information on alcohol-related policies at the State and Federal levels in the United States based on primary legal research on the statutes and regulations. The APIS was developed by the NIAAA to facilitate research on the effects and effectiveness of alcohol-related public policies. APIS provides detailed coverage, including exact effective dates and legal citations, for 35 specific policy topics in 8 categories:

Underage Drinking

Blood Alcohol Concentration (BAC) Limits

Transportation

Taxation

 Retail Sales

Alcohol Control Systems

Pregnancy and Alcohol

Health Care Services and Financing

For each policy topic, APIS provides detailed comparison tables showing both up-to-date policy information and policy changes over time with exact effective dates. APIS also provides descriptive overviews, maps and charts, summaries of relevant Federal law, and detailed explanatory notes. Coverage for most topics begins at January 1, 1998 and extends through January 1, 2010. One purpose of this FOA is to encourage studies that will make use of the information available through APIS.

Additional information on policies may be obtained through a variety of sources, including legal information resources, government offices and agencies, and public health, trade, and advocacy organizations that compile information on policies in their areas of interest. Sources of policy information in other areas related to public health include the Centers for Disease Control and Prevention’s State Tobacco Activities Tracking and Evaluation (STATE) System (http://apps.nccd.cdc.gov/statesystem/), the National Conference of State Legislatures’ Substance Abuse Legislation Database (http://www.ncsl.org/programs/health/substAbuse_bills.cfm), the National Highway Traffic Safety Administration’s Digest of Impaired Driving and Selected Alcohol Beverage Control Laws (http://www.nhtsa.dot.gov/people/injury/alcohol/ImpairedDrivingBeverageControlDigest.pdf), the National Cancer Institute's State Cancer Legislative Database (http://www.scld-nci.net/), and the Bureau of Alcohol, Tobacco, Firearms and Explosives publication, State Laws and Published Ordinances - Firearms (http://www.atf.gov/publications/firearms/state-laws/29th-edition/index.html). Policy information from these and other areas may be useful in examining how policies interact to influence health-related outcomes.

Some studies of policy effects have examined the direct relationship between policy variables and outcomes of interest, such as the direct relationship between alcohol excise tax rates and traffic crash fatalities. Other studies have attempted to examine elements of the behavioral linkages that connect policy changes and downstream effects on specific outcomes, such as the effects of alcohol taxes on alcohol prices, the effects of prices on consumption behavior, and the effects of alcohol consumption behavior on traffic outcomes. Both approaches are valid, and each presents its own conceptual and methodological challenges. A literature that includes both perspectives should provide greater insight into the effects and mechanisms of public policies on behaviors and outcomes than a body of research that is restricted to either approach alone.

Alcohol-related public policies occur within complex policy environments that generally include multiple policies that affect various aspects of alcohol-related behaviors and outcomes.  Analytic approaches that can examine the simultaneous influences of multiple policies and the potential interactions among such policies may yield insights beyond those that can be obtained by analyzing the effects of individual policies in isolation.

Beyond the mere existence of particular statutes or regulations, differences in how policies are implemented can also influence the extent to which they achieve desired (or undesired) effects. Key aspects of implementation include the dissemination of public information pertaining to policy changes, the extent of enforcement efforts and publicity about enforcement, and the nature and severity of penalties associated with violations. Empirical studies that incorporate measures of enforcement or other aspects of implementation often confront significant challenges in terms of measurement and data availability. This FOA seeks to encourage studies that can add to our understanding of the role of enforcement, public information, and other aspects of implementation in determining policy effects.

Public policies influence behaviors and outcomes within the broader social context in which the policies are enacted and implemented. For example, the factors that lead some jurisdictions to adopt policies different from those in otherwise similar jurisdictions may have significant implications for (or reflect the influence of additional factors that also affect) the health, social, and economic outcomes that obtain in such jurisdictions. Research on the process of policy diffusion and determinants of policy formation may enhance understanding of the role of policy as a tool for influencing health and other outcomes and help researchers to choose appropriate analytic strategies for incorporating policy variables into studies of causal relationships.

Because alcohol consumption is associated with a wide range of health conditions, policies that affect health care service delivery, financing, access, and utilization can have significant effects on the magnitude and severity of alcohol-related health outcomes. Insurance policies may specify coverage limits for treatment of alcohol use disorders under the broader headings of substance abuse treatment or mental health services.  Historically, insurance coverage for these categories has sometimes been more restrictive than coverage for general health conditions. State and Federal policies enacted in recent years have placed limits on the extent to which insurance coverage for treatment of substance abuse and mental illness may differ from coverage for treatment of other conditions.  Differences may persist in some contexts, however.  Differences in insurance provisions across jurisdictions, health conditions, groups of insured individuals, and over time may create natural experiments that can reveal how  alcohol-related behaviors and outcomes respond to variations in health insurance coverage. Similarly, laws allowing insurers to deny coverage for treatment of injuries sustained as a result of intoxication (so-called UPPL laws) may provide a disincentive for health care providers to identify, document, and make appropriate referrals for possible alcohol use disorders among injury victims. The broad and complex body of public policy that applies to health care providers, facilities, services, and programs as well as to financing and insurance arrangements (both public and private), has the potential to influence alcohol-related behaviors and outcomes in numerous and important ways.

In addition to studies of the effects of specific policies on outcomes of interest, this FOA also aims to encourage research that evaluates the effectiveness of specific policy measures as tools for improving public health or reducing the burden of alcohol-related illness and mortality. Such studies may use techniques of cost-effectiveness analysis or other accepted methods and should adopt a societal perspective as a primary basis for comparisons unless compelling reasons for an alternate perspective arise based on the specific policies or policy effects under consideration.

This FOA particularly encourages research to assess the effectiveness of various state-level restraints on the market behavior of sellers, distributors, and producers of alcoholic beverages in reducing harmful alcohol consumption and adverse alcohol-related outcomes or increasing the prevailing prices for alcoholic beverages.  Based on the powers delegated to states under the Twenty-first Amendment to the U.S. Constitution, individual states have established various policies pertaining to the distribution and sale of alcoholic beverages.  Recent court cases initiated in the States of Maryland and Washington and reviewed by the Fourth and Ninth Circuit Courts of Appeal, respectively, have examined the extent to which some of these policies may violate other statutes, notably the Sherman Act that limits anti-competitive behavior, and the appropriate roles of the Sherman Act restrictions compared to Twenty-first Amendment authorities in determining the permissibility of such policies.  The courts explicitly considered questions of whether state restrictions that otherwise might violate the Sherman Act were effective in advancing the States’ compelling interests under the Twenty-first Amendment, and found insufficient evidence to establish the effectiveness of the policies in raising prices for alcoholic beverages or in promoting "temperance" (the courts' term).  Thus, one objective of this FOA is to provide high-quality scientific evidence to inform future consideration of these and similar questions.

Accurate assessment of the effects of public policies on outcomes of interest requires accurate measurements of policy status in the jurisdictions under study. Accuracy in characterization of the statutory and regulatory provisions that comprise many policies, such as the information available through the Alcohol Policy Information System, is a necessary component of such measurement. However, some policies may be characterized by multiple provisions in more complex combinations. In such cases, it may be necessary to create synthetic measures of policy status, such as an index number reflecting the stringency of policy in a particular area. Areas of alcohol-related policy where such indices or other synthetic measures of policy status may be especially useful include underage drinking, alcohol taxation, and alcohol-related traffic policies. An additional objective of this FOA is to encourage development, testing, and application of alternate approaches to measurement of policy status in these and other areas where characterizations based on direct representations of legal provisions may not be adequate for research purposes.

Many different alcohol-related public policies are appropriate for examination under this FOA. For any given policy topic or topic area, potentially researchable questions arise concerning the direction, magnitude, heterogeneity, and mechanisms of policy effects on outcomes of interest. Depending on the specific policy or policies under consideration, outcomes of interest may include (but are not limited to):

In addition to policy effects on alcohol-related health, behavioral, and social outcomes of the sorts identified above, policies may have wide ranging additional effects, including adverse or unintended consequences. Evaluations or comparisons of policies should give consideration to the additional benefits or burdens that may be attributable to policies.

Previous studies often have examined policy effects on selected outcomes at the level of the study population as a whole. However, better understanding may be gained by examining differential policy effects on relevant subpopulations. Groups of particular interest may be defined by age, gender, drinking categories, socioeconomic status, education, race/ethnicity, geographic location, or other traits. This FOA seeks to encourage research that will expand understanding of how policy effects differ across relevant subsets of the population. Such information can help decision-makers assess the potential value of specific policy tools in efforts to address particular aspects of alcohol-related problems.

Examples of policy topics and potentially associated outcomes that could be examined with support under this FOA include (but are not limited to):

Examples of additional policy-related research questions with a somewhat broader focus that could be addressed under this FOA include:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Revision
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types

Funds Available and Anticipated Number of Awards

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

Award Budget

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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.

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is two 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 (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

Appendix

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

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

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

Applicants are responsible for viewing their application 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 SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). 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.

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

Overall Impact

Reviewers will provide an overall impact/priority 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/PIs, 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/priority 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/priority 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)  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

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:

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 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, CCR 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Gregory Bloss
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: gbloss@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, GMO
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 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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