It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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 Funding Opportunity Announcement (FOA) encourages applications to conduct research on the effects of public policies on health-related behaviors and outcomes associated with alcohol, marijuana, and other substances. The purpose of the FOA is to advance understanding of how public policy may serve as a tool for improving public health and welfare through its effects on behaviors and outcomes pertaining to alcohol and other drugs. This FOA is intended to support innovative research to examine policy effects that have the potential to lead to meaningful changes in public health. Research projects that may be supported by this FOA include, but are not necessarily limited to: causal analyses of the effects of one or multiple public policies; evaluations of the effectiveness of specific public policies as tools for improving public health through their effects on alcohol-, marijuana-, and other substance-related behaviors and outcomes; and research to advance methods and measurement used in studying relationships between public policies and alcohol-, marijuana-, and other substance-related behaviors and outcomes.

This FOA seeks to expand knowledge about the effects of public policies on health-related behaviors and outcomes associated with alcohol, marijuana, prescription drugs, opiates, tobacco, and other substances. Such knowledge can inform discussions and decisions about public policies that ultimately lead to improvements in public health and welfare. The specific objectives of this FOA are to support innovative research that: (a) identifies and quantifies the causal effects of public policies on alcohol-, marijuana-, and other substance-related behaviors and outcomes; (b) evaluates the effectiveness of policy measures in improving health through their effects on such behaviors and outcomes; (c) elucidates the behavioral linkages through which public policies affect intervening attitudes, behaviors, incentives, or other factors that ultimately affect health-related behaviors or outcomes; and (d) advances methods and measurement used in studying relationships between public policies and alcohol-, marijuana-, and other substance-related behaviors and outcomes.

This FOA is intended to support innovative research that examines policies and policy effects that are not well understood; it is not intended to reinforce or add nuanced detail to extant knowledge about policies that have been studied extensively. Examples of well-researched topics that are not expected to be supported by this FOA are studies of the effects of alcohol excise taxes on alcohol consumption or related problems, and the effects of the minimum legal drinking age on similar outcomes. However, research on other policies that may affect underage drinking is still needed. Studies that make use of policy information provided in NIAAA's Alcohol Policy Information System (http://alcoholpolicy.niaaa.nih.gov) and/or the Prescription Drug Abuse Policy System (http://pdaps.org) developed by NIDA are particularly encouraged.

Applications that propose to conduct health economics research should be consistent with current NIH priorities for health economics research. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-025.html for more details.

Grants under this announcement may not be used to promote enactment, adoption, or repeal of any specific public policies. Applicants are advised to review and adhere to all anti-lobbying provisions that apply to Federal research grants.

Alcohol and drug consumption are widespread in the United States and many other countries and can have important effects on health, social, and economic behaviors and outcomes. These effects are diverse in character and encompass a wide variety of health conditions, both chronic and acute. Additional individual-level effects may affect development and maturation, educational achievement, employment, productivity, violent and criminal behavior and victimization, health care utilization, and family and interpersonal relations. Effects of alcohol and drug consumption also may be manifest at higher levels of aggregation, such as in groups, communities, subpopulations, markets, and institutions, for example through effects on behavioral norms and cultural mores, commercial activity and market outcomes, tax revenues, budgetary allocations for criminal justice expenditures, and health care practices.

In the United States, a large and diverse set of public policies addresses a wide range of behaviors associated with alcohol and drugs. For alcohol, governments at all levels have established laws, regulations, and case law affecting 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. A similarly rich set of policies are in place to address tobacco manufacture, sales, use, and cessation treatments.

For marijuana, public policies in the United States are in flux. U.S. Federal law continues to prohibit possession, use, cultivation, and sale of marijuana for both medical and non-medical purposes. However, many states have enacted policies that permit medical use of cannabis products for various health conditions; these policies vary in their provisions pertaining to possession, cultivation, taxation, sales, and distribution. In addition, some state- and local-level jurisdictions have taken steps toward decriminalizing possession and use of small amounts of marijuana, while several states and DC have legalized marijuana for recreational use. In contrast, public policies toward other illicit drugs, such as cocaine, methamphetamine, and heroin, have remained relatively constant.

Prescription medications are subject to laws and regulations established by both Federal and state governments. Examples include prescription drug monitoring programs, policies to prevent doctor-shopping and to disrupt the operation of rogue pain clinics or pill mills , and other laws to reduce prescription drug diversion. A common challenge confronting policies intended to reduce prescription drug abuse is the need to safeguard legitimate access to pain management and other appropriate medical uses of these drugs.

Alcohol, tobacco, marijuana, and other substances have seen ongoing innovation in formulation, packaging, marketing, and delivery of these products, complicating the challenges confronting both researchers and policy-makers. Recent examples include the introduction of energy drinks and caffeinated beverages containing alcohol; approval of a powdered form of alcohol for commercial sale; the widespread availability and marketing of electronic cigarettes and the use of vaporizing delivery systems for delivery of other substances (i.e., cannabis); and a variety of cannabis products such as concentrates, edibles, and synthetic cannabinoids. Public policies often are proposed in response to adverse events resulting from such changes in the market. Research is needed to inform effective public health strategies in these areas.

In addition to policies that aim to affect behaviors and outcomes associated with alcohol, marijuana, and other substances, such behaviors and outcomes may also be influenced by policies whose primary intended effects are in other areas. Examples may include traffic safety laws, child labor laws, child welfare policies, housing and education programs, import/export rules, taxation policies, and zoning regulations. Identifying unintended policy effects on alcohol-, marijuana- and other substance-related behaviors and outcomes can inform decision-making about those policies and about related needs for enforcement and for prevention and treatment services.

Because consumption of alcohol, marijuana, and other substances are 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 substance-related health outcomes. Differences in insurance provisions across jurisdictions, health conditions, groups of insured individuals, and over time may create natural experiments that can reveal how 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-, marijuana-, and other substance-related behaviors and outcomes in numerous and important ways.

Effects of public policies may vary across individuals and population groups, including those defined by age, gender, race, ethnicity, region, urbanicity, socio-economic status, or other relevant characteristics. Policy effects may also vary by health-related attributes, including health status and risk factor exposure. For policies that affect alcohol-, marijuana-, and other substance-related behaviors and outcomes, policy effects that vary systematically with consumption levels and related behaviors are of particular concern. A key objective of this FOA is to encourage identification and analysis of differential policy effects across subgroups of interest.

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. Unintended effects arising from implementation and enforcement efforts may differ from those associated with the policy itself, and include both immediate and longer-term consequences resulting from imposition of penalties as well as behavior changes that may result from such efforts. 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 on alcohol-, marijuana- and other substance-related behaviors and outcomes.

By their nature, public policies can have broad consequences for behaviors and outcomes, including unintended effects that may reinforce, dilute, or be unrelated to the intended effects. Advancing knowledge of the nature and magnitude of actual effects, both intended and unintended, of public policies on behaviors and outcomes is a critical opportunity for scientific contribution to improvements in human welfare. In addition, 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.

Identifying, quantifying, and evaluating effects that are caused by a given policy or set of policies is an analytic challenge due in part to the infeasibility of randomized controlled experiments for most policy interventions. Strong research designs and valid measurement of both the behaviors and outcomes of interest and the policy interventions that may affect them, as well as relevant mediating and moderating factors, are necessary to support meaningful conclusions regarding causal relationships. 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 substance use. For example, substantial evidence indicates that 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, averting a total of more than 300,000 deaths. However, these changes occurred over a period that included many other economic, social, and cultural changes. The challenge of discerning the causal influence of any particular policy or group of policies on specific outcomes of interest in the presence of numerous confounding factors is one of the main challenges of policy research. This FOA encourages studies that surmount these difficulties as well as studies that advance the methodologies available for conducting such analyses.

A variety of research designs may be appropriate to assessing the effects of public policies on health-related behaviors and outcomes associated with alcohol, marijuana, prescription drugs, opiates, tobacco, and other substances. 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 public policies commonly take the form of natural experiments: secondary analyses of outcome or problem indicator data and relevant covariates observed before and after policy changes take 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 may be attributable to other, possibly unobserved factors. 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.

This FOA also encourages applicants to consider using systems science approaches to the study of alcohol, marijuana and other substance use related policy. Systems science methodologies (i.e., systems-based simulation modeling methods) such as agent-based, microsimulation, network, or system dynamics modeling are well-suited to examining the complexities of real world phenomena such as public policies that affect alcohol- and drug-related behaviors and outcomes. Systems science methods are complementary to those described above and are particularly useful for capturing heterogeneous effects, 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. Transparency in documenting the structure and calibration of such models is essential to establishing the credibility of simulation modeling 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 model validity and the quality of model results. Applications that incorporate sophisticated spatial-temporal thinking to take advantage of advances in geospatial technologies and spatially-referenced data are also encouraged.

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, marijuana, and other substances 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 and other drug-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 (http://pubs.niaaa.nih.gov/publications/2012DataDirectory/2012DataDirectory.htm) and the National Drug Abuse and HIV Data Archive (NAHDAP) hosted by ICPSR (http://www.icpsr.umich.edu/).

Accurate assessment of the effects of public policies on outcomes of interest requires accurate measurements of policy status in the jurisdictions under study. Public policies are established through political and regulatory processes and documented primarily as statutes and regulations. Several existing resources provide reliable information on policies in areas relevant to this FOA.

Alcohol Policy Information System. The Alcohol Policy Information System (APIS; available at http://alcoholpolicy.niaaa.nih.gov) is an 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 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 36 specific policy topics in 10 categories (taxation; underage drinking; alcohol beverages pricing; blood alcohol concentration (BAC) limits; transportation; retail sales; alcohol control systems; pregnancy and alcohol; health care services and financing; recreational use of cannabis). The recently-added policy topic on Recreational Use of Cannabis encompasses 10 distinct elements of cannabis policy. For every 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, 2016 with annual updating. One purpose of this FOA is to encourage studies that will make use of the information available through APIS.

Prescription Drug Abuse Policy System. The Prescription Drug Abuse Policy System (PDAPS; available at http://pdaps.org) is an online data resource that provides authoritative, detailed, and comparable information on prescription drug abuse prevention policies at the state level in the United States. The site contains policy data on three topics based on scientific legal research on the statutes and regulations and will likely be expanded to include other topics. The PDAPS was developed by the NIDA to facilitate research on the effects and effectiveness of prescription drug abuse prevention policies. PDAPS currently provides detailed longitudinal coverage, including exact effective dates, legal citations, and publically available versions of the legal text for 4 specific policy topics (Naloxone Administration, Prescription Drug Monitoring Program Administration, Good Samaritan laws, and Medical Marijuana). For each policy topic, PDAPS provides a descriptive overview of the policy context and allows users to interact with maps and tables showing policy information and policy changes over time. In addition, a lay person can interact with the data through a robust question and answer interface. The PDAPS contains downloadable data with full codebooks, protocols and 1-page policy briefs. Naloxone Administration includes laws from January 1, 2001 through July 1, 2016. Good Samaritan laws are covered from January 1, 2007 to July 1, 2016. Prescription Drug Monitoring Program Administration covers three types of laws from January 1, 1998 to July 1, 2016. Medical Marijuana covers 4 types of laws from January 1, 2014 to July 1, 2016. All covered laws will be kept up to date in real-time. Additional topic domains will be added over the next several years. One purpose of this FOA is to encourage studies that will make use of the information available through PDAPS.

State Health Practice Database for Research. The State Health Practice Database for Research (SHPDR; available at http://www.shpdr.org) is a new resource of state-level data on health practices for conducting theoretical and applied research to understand how innovations in treatment, diagnosis, and preventive strategies can be most effectively deployed to improve health and well-being. Developed with support from the NIH, the SHPDR is designed to support research investigating the diffusion of medical technology and other health services research outcomes of interest. The SHPDR contains state-level data on healthcare-related statutes and regulations to support clinical, health economics, and technology-related research. The data included in the SHPDR includes a series of topics, subtopics, and variables organized under two primary domains, Provider and Insurance, highlighting the significant role that providers and insurers play in healthcare delivery and the evolving healthcare delivery and payment market.

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 LawAtlas (http://lawatlas.org); 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 policies may be characterized by multiple provisions in complex combinations. In such cases, it may be useful to create synthetic measures of policy status, such as index numbers reflecting the stringency of policy in a particular area. Areas where such indices or other synthetic measures of policy status may be especially useful include underage drinking, legal status of cannabis, and policies that address driving while impaired by alcohol and/or drugs. 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.

This FOA particularly encourages research to assess the effectiveness of state-level policies pertaining to the sale, distribution, and production 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. Court cases 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). As regulated market-like arrangements for sale of cannabis products for medical or recreational uses are established in different states, similar questions may arise regarding the authority of state governments to impose regulations on sellers of these products as well. One objective of this FOA is to provide high-quality scientific evidence to inform future consideration of these and similar questions.

This FOA encourages studies that identify and measure disparities in the causal effects of public policies on alcohol-, marijuana- and other substance-related behaviors and outcomes among population subgroups, including those defined by race, ethnicity, age, sex, socio-economic status, or other relevant characteristics.

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

• Effects of policies addressing underage drinking and access to alcohol on behavior and outcomes among young adults and their younger peers, including both short-term effects on behavior and possible longer-term effects of restrictions on youth access to alcohol on subsequent developmental and health-related outcomes.
• Effects of changes in the legal status of marijuana on health-related behaviors and outcomes, such as traffic and other injuries in which alcohol, marijuana, other drugs, or combinations of these substances are involved; health care utilization, practice, or health policy; and broader measures of the economic impact on society of alcohol-, marijuana-, and other substance-related behaviors and outcomes.
• Effects of policies aimed at reducing access to prescription opiates on opiate use, other health services utilization, and behaviors and outcomes associated with illicit opiates and other substances.
• Effects of variations in the legal provisions applicable to legalized marijuana, such as days and hours of legal sale, taxation, outlet locations and density, restrictions on who can sell, minimum age for purchase, and restrictions on advertising and marketing, on health-related behaviors and outcomes.
• Effects of repealing UPPL laws, or enactment of laws prohibiting denial of insurance benefits for losses due to the intoxication of the insured, on behavior and practice patterns of health care providers, on subsequent utilization and costs of health care services, and on subsequent alcohol-related health consequences.
• Effects of policies pertaining to consumption of alcohol, marijuana, and other substances by pregnant women or policies affecting access to treatment for alcohol and substance use disorders by pregnant women on health-related outcomes for women, their children, and the broader community.

Examples of additional policy-related research questions with a somewhat broader focus that could be addressed under this FOA include (but are not limited to):

• Through what mechanisms, and among which population groups, do policies that are effective in reducing adverse alcohol-related outcomes operate? Do they reduce the prevalence of consumption, the frequency of consumption, the maximum number of drinks per occasion, the frequency of heavy drinking occasions, or the risks of various adverse consequences associated with these behaviors?
• Do policy strategies similar to those that have been applied to alcohol have similar or differential effects when applied to marijuana?
• Does legalization of marijuana lead to increases, decreases, or no change in use or alcohol or other substances or in simultaneous use of combinations of substances?

See Section VIII. Other Information for award authorities and regulations.

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).

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

It is critical that applicants follow the Research (R) 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:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

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.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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

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.

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.

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

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

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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 National Advisory Council on Alcohol Abuse and Alcoholism or the National Advisory Council on Drug Abuse. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final 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.

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

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Gregory Bloss, M.A., M.P.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: [email protected]

Heather L. Kimmel, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

Carolyn Reyes-Guzman, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7244
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]

Jennifer Schermerhorn
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6704
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
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 Part 75.