Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

The purpose of this notice of funding opportunity (NOFO) is to support policy research projects that examine new or adapted policies pertaining to tobacco, alcohol, and/or cannabis in the U.S., with a particular focus on how the policy or policies influence tobacco, alcohol, and cannabis use or secondhand exposure among populations experiencing disparities. Funded projects will involve authentic engagement with one or more community organizations with the aim of promoting equity in cancer prevention by addressing tobacco, alcohol, and cannabis use and exposure. The long-term goal is to support tobacco, alcohol, and cannabis policy research studies that will improve health equity and promote cancer prevention.

Whereas this NOFO is for well-developed projects supported by preliminary data, there is a companion PAR-25-241 of identical scientific scope meant for pilot/exploratory projects.

Key Definitions and Terms for this NOFO

Cannabis: A plant that contains naturally occurring compounds called “cannabinoids,” including cannabidiol (CBD) and tetrahydrocannabinol (THC). This includes hemp, a type of cannabis that is low in THC (cannabis or cannabis derivatives containing no more than 0.3% THC on a dry weight basis). Cannabis-derived compounds are those naturally occurring in the plant (CBD and THC). Cannabis-related compounds are synthetic compounds created in a laboratory, such as synthetically derived dronabinol (also naturally occurring) and nabilone (not naturally occurring).

Community Organization: A non-federal, non-academic, non-research organization that provides goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations, local businesses, neighborhood authorities and associations, labor unions, patient or consumer advocacy groups, public health departments, regional/local and public healthcare systems, school districts, law enforcement or criminal/juvenile justice agencies, social service agencies, or departments of commerce, labor, transportation, housing, and recreation. Governmental organizations at the local, state, regional, or tribal level fall within this definition.

Secondhand Exposure: Passive or involuntary inhalation of tobacco or cannabis smoke/vapor from a burning/aerosolized product or exhaled by users. Also known as secondhand or environmental smoke/vapor.

Policy: A law, regulation, ordinance, rule, procedure, administrative action, incentive, or voluntary practice of governments and other institutions. It is a deliberate statement of intent and is implemented as a procedure or protocol. Policy decisions may be reflected in resource allocations.

Policy Research: Studies that systematically examine a policy, including formulation (e.g., what should the policy be based on available evidence?), adoption (e.g., what factors influence uptake of policy adoption?), implementation (e.g., how should the policy be put into practice?), and evaluation (e.g., what is the effect of the policy on an outcome?).

Population(s) Experiencing Disparities: As defined by the National Institute on Minority Health and Health Disparities, “a health disparity is a health difference that adversely affects disadvantaged populations, based on?higher incidence and/or prevalence and earlier onset of disease; higher prevalence of risk factors, unhealthy behaviors, or clinical measures in the causal pathway of a disease outcome; higher rates of condition-specific symptoms, reduced global daily functioning, or self-reported health-related quality of life using standardized measures; premature and/or excessive mortality from diseases where population rates differ; and greater global burden of disease using a standardized metric.” Health disparities are closely linked with social, environmental, and/or economic disadvantage. Health disparities adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group, religion, socioeconomic status, gender, age, mental health, cognitive, sensory or physical disability, sexual orientation or gender identity, geographic location (place/context), other vulnerable populations such as the incarcerated or recently incarcerated, or other characteristics historically linked to discrimination or exclusion. This NOFO is focused on health disparities as regards the risk factors or unhealthy behaviors of tobacco, alcohol, and cannabis use or secondhand exposure. The NOFO requires that studies focus on one or more “population(s) experiencing disparities in tobacco, alcohol, and/or cannabis use or secondhand exposure,” also referred to as “population(s) experiencing disparities,” or “population(s) of interest.”

Tobacco Product: Defined by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321, is “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product.”

Background

Tobacco, alcohol, and cannabis are the most commonly used substances in the U.S., and disparities in use and exposure contribute substantially to health inequities. Moreover, co-use of tobacco, alcohol, and cannabis is common. Recent trend analyses using the National Survey on Drug Use and Health data suggest an increase in the co-use of cannabis with alcohol and cannabis with cigarettes, whereas co-use of alcohol with cigarettes has declined. Tobacco products cause nearly 30% of cancer mortality. In addition, alcohol causes over 4% of cancer deaths. Research examining the influence of cannabis use on health outcomes is emerging.

In the U.S., tobacco control efforts between the 1964 Surgeon General’s report and 2012 are estimated to have prevented 8 million premature deaths. The overall decline in tobacco use prevalence in the U.S. masks considerable differences in adult cigarette smoking prevalence among subpopulations related to income, level of educational attainment, race/ethnicity, sexual orientation, gender identity, place of residence, health insurance coverage, the presence or absence of co-morbid mental health conditions and/or substance abuse, among numerous other factors and intersections of these and other social circumstances and social identities. Disparities exist for alcohol and cannabis use as well. For example, lifetime prevalence of alcohol use disorder is highest for those with lower income; people with lower income may experience disproportionate harms from similar levels of alcohol consumption found in those with higher income. Also, weekly or monthly cannabis use and dependence are more prevalent among Black adults, Native American adults, and mixed-race adults than White adults. Furthermore, disparities in co-use exist.

Policies can influence substance use and exposure, and Federal, state, and local policies are continually changing. For example, in recent years, tobacco flavor bans have taken effect in five states, with Massachusetts and California prohibiting the sale of both flavored e-cigarettes and menthol cigarettes, and an amendment to the Federal Food, Drug, and Cosmetic Act raised the federal minimum age for tobacco product sales from 18 to 21 effective January 1, 2020. Although cannabis is illegal federally, increasing numbers of U.S. states and territories allow medical and non-medical use of cannabis. The Alcohol Policy Information System (APIS), which tracks policy changes across the 50 states and the District of Columbia, has identified more than 950 policy changes related to alcohol since 2003. Public health policy can be a cost-effective tool for influencing health behaviors such as substance use, and preliminary evidence suggests that changes in policies focused on one substance can influence the use of other substances as well. For example, changes in cannabis policy may influence alcohol use, although the influence may depend on the type of policy being implemented, the alcohol use outcome being measured, and the specific population being studied. Moreover, implementation of smoke-free policies may decrease alcohol consumption among some groups of smokers. With such a rapidly changing policy environment, disparities in use, co-use, and secondhand exposure may change for better or for worse. Evidence-based policies rooted in public health may prevent or mitigate disparities. Policies could also, through unanticipated effects or otherwise, exacerbate existing disparities or contribute to emerging disparities.

Given that use and exposure disparities exist, and that use and co-use of these three substances is common, it is essential to consider the direct and indirect effects of policies that target one substance on the use of other substances, particularly in populations experiencing disparities. Research is therefore needed to assess the impact of federal, state, and local tobacco, alcohol, and cannabis policies on the use or secondhand exposure of all three substances, and to determine how these effects might differ in ways that create, ameliorate, or exacerbate disparities.

Research Objectives

Broadly, this NOFO is intended to encourage research projects that focus on populations experiencing disparities in tobacco, alcohol, and cannabis use or secondhand exposure by examining new or adapted policies pertaining to tobacco, alcohol, and/or cannabis in the U.S. The results of funded projects will advance equitable tobacco, alcohol, and cannabis policies.

Specific research topics that fall within the scope of this PAR would include, but would not be limited to, changes in tobacco, alcohol, and cannabis use or secondhand exposure among populations that experience disparities associated with the following types of policies:

• Comprehensive smoke-free environment policies, including smoke and vapor from cannabis products (e.g., smokefree school campus policies that extend to nicotine and cannabis vaping products);
• Policies that reduce the appeal of tobacco, alcohol, or cannabis products through advertising or marketing restrictions, package design requirements, and flavor bans;
• Policies that reduce the demand for products with pricing interventions (e.g., minimum unit pricing; taxation);
• Policies related to the sale of tobacco, alcohol, or cannabis (e.g., legalization/authorization, age restrictions, retailer licensing and density, days and hours of legal sale);
• Policies related to the treatment coverage for tobacco use, alcohol use disorder, or cannabis use disorder (e.g., Federal, state, local, and institutional policies influencing access to, affordability, and use of treatment services);
• Overarching policy environment (e.g., studies that examine the dynamic interplay of different types of policies on tobacco, alcohol, and cannabis use or secondhand exposure; how policies may work synergistically to reduce use or secondhand exposure).

All projects must include:

• A focus on one or more populations experiencing disparities in tobacco, alcohol, and/or cannabis use or secondhand exposure.
• A focus on at least one policy pertaining to tobacco, alcohol, or cannabis.
• Individual- or population-level measurement of tobacco, alcohol, and cannabis use or secondhand exposure with and without a policy (either before and after, or in the absence and presence of, a policy); pre-post and comparative study designs are acceptable.
  • Of note:
    • Projects are required to measure use of or secondhand exposure to all three substances, irrespective of the target substance of the policy.
    • Investigators should propose specific outcome measures (e.g., current use, flavored tobacco product use, frequency of binge drinking) as they are relevant to and appropriate for evaluating the policy and the research question.
    • Longitudinal data on a cohort of individuals is not required; repeated cross-sectional surveys or other study designs may be proposed if data are available or collected with and without a policy.
    • Applicants may also consider including health outcomes.
• Collaboration and partnership with a community organization.
  • Of note:
    • Projects must demonstrate a meaningful partnership with a relevant community organization, from conception to dissemination, to foster the development of feasible, acceptable, and scalable policy approaches.
    • Projects must provide details on the nature and extent of the partnership. It is expected that the partner community organization will have a substantial role in the implementation of the proposed study.
    • Interested applicants can learn more about the Centers for Disease Control and Prevention, Office on Smoking and Health’s “National Networks Driving Action”, which are consortia that provide leadership on and promote evidence-based approaches for preventing commercial tobacco use and cancer to increase equitable delivery of tobacco prevention and cancer-related strategies and related interventions. (https://www.cdc.gov/tobacco/php/tobacco-control-programs/coop-agreement.html).
    • Interested applicants can learn more about the Centers for Disease Control and Prevention, Office on Smoking and Health’s National and State Tobacco Control Program, which provides funding and technical support to state and territorial health departments (https://www.cdc.gov/tobacco/php/tobacco-control-programs/index.html).
    • Interested applicants can learn more about the Centers for Disease Control and Prevention, Division of Cancer Prevention and Control’s National Comprehensive Cancer Control Program, which supports programs to design and implement impactful, strategic, evidence-based, and sustainable plans to prevent and control cancer. All 50 states, the District of Columbia, 7 U.S. Pacific Island jurisdictions and Puerto Rico, and 7 tribes and tribal organizations have produced 65 plans. (https://www.cdc.gov/comprehensive-cancer-control/about/programs.html)
    • The investigative team and partner community organization are encouraged to build workforce development plans for interested members of the partner organization and assist them with capacity building.
• An overall strategy that builds upon rigorous dissemination and implementation science.
• A dissemination plan appropriate for the research question and the nature of hypothesized results to relevant communities. Applicants are also encouraged to consider how and to whom they will disseminate findings to if findings demonstrate that a policy has harmful consequences for populations experiencing disparities.

Applications may propose various methodologies, including, but not limited to:

• Natural experiments
• Randomized control trials
• Modeling studies
• Observational research, such as ecological and longitudinal study designs

In developing their research questions and study designs, applicants are encouraged to consider the wider context, including other policies that may be potential moderators, the degree of policy enforcement, and the mode of product use (e.g., smoke, vape, ingest). Moreover, applicants are also encouraged to examine the intersectionality of social circumstances and social identities.

Non-Responsive Applications

The following applications are not responsive and will not be reviewed:

• Applications or research projects focused on biological mechanisms or disease processes.
• Studies that do not examine at least one tobacco, alcohol, or cannabis policy and focus on at least one population experiencing disparities in tobacco, alcohol, or cannabis use or secondhand exposure.
• Studies that do not assess tobacco, alcohol, and cannabis use or secondhand exposure with and without a policy.
• Projects that do not include a meaningful community partnership. Projects that include a partner community organization only as part of an advisory board will not be considered responsive.
• Projects focusing on populations outside of the United States.

Grantee Meetings

Awardees will be expected to participate in periodic investigators' meetings that may be hosted by NCI in-person or virtually. The meetings will provide a forum for presenting scientific findings from each of the funded studies and will facilitate interactions among the community of funded scientists.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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).

Federal Governments

• 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 Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply-Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

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

Research Strategy: The entire Research Strategy must adhere to the general requirements listed in Section I of this FOA. The subsections indicated below should also address the following specific aspects.

Factor 1: Importance of the Research

Significance: Identify the population(s) of interest. Define and describe the burden of tobacco, alcohol, and cannabis use or secondhand exposure in the population(s). Discuss the potential for generalizability of findings from the proposed study for additional contexts and populations. Identify and describe the policy that will be studied.

Innovation: Describe the hypothesized effects the policy will have on use of or exposure to all three substances in the population(s) of interest.

Factor 2: Rigor and Feasibility

Approach: This subsection must address and provide the necessary supporting details explaining how the proposed project will meet the following key requirements:

Tobacco, Alcohol, and Cannabis Use/Exposure Assessment: Include a detailed assessment, appropriate for the research design, of tobacco, alcohol and cannabis use or secondhand exposure. Use or secondhand exposure must be measured with and without a policy. Investigators are strongly encouraged to use standard data collection measures to the extent possible given the scientific areas covered in the proposed project.

Dissemination and Implementation: Demonstrate how the approach will build upon rigorous dissemination and implementation science.

This subsection may also demonstrate how the study design accounts for the wider context by identifying potentially influential external factors (e.g., other policies, mode of administration, degree of policy enforcement) and incorporates them into statistical analyses and plans for interpretation of results.

Factor 3: Expertise and Resources

Investigators: Describe the investigative team’s relevant expertise in health disparities and experience working with populations experiencing disparities.

Environment: Describe the role and responsibilities of the partner community organization(s) with respect to all phases of the project, including informing the research questions, determining and providing input on the approach, interpretation of results, and dissemination. Describe the plans for sustaining collaborations between the investigative team and the community partner(s).

Letters of Support: In addition to standard letters of support, include other letter(s) of support documenting the planned community partnership(s). It is expected that the partner community organization will have a substantial role in the implementation of the proposed study. Partner community organization(s) should provide evidence of commitment and support through this letter of support, explaining the specific roles and responsibilities they will have throughout the research project, such as identifying and informing research questions, informing the design of the study, recruiting participants, collecting data, analyzing data and interpreting results, and disseminating findings. The letters of support should also demonstrate a commitment to, and describe plans for, sustaining the collaboration beyond the project funding period.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

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

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission 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 scored review criteria and additional review criteria (as applicable for the project proposed).  An application does not need to be strong in all categories to be judged likely to have a major scientific impact. As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific review (CSR) 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 will receive a written critique.

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.

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 submitted in response to this NOFO. 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, consistent with applicable law.

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

Please note that reviewers will not consider race, ethnicity, age, or gender of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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. 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Awardees will provide updates at least annually on implementation of the PEDP.

A final RPPR, 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Margaret Mayer Sutherland, PhD, MPH
National Cancer Institute (NCI)
Telephone: 202-815-5515
Email: [email protected]

Annette Kaufman, PhD, MPH
National Cancer Institute (NCI)
Telephone: 301-467-8521
Email: [email protected] 

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

Erik J. Rodriquez, Ph.D., M.P.H.
NIH Office of Disease Prevention (ODP)
Phone: (301) 827-2830
E-mail: [email protected]

Heather L Kimmel
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-443-8769
E-mail: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]
 

Priscah Mujuru, DrPH, MPH, RN, COHN-S
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-9765
E-mail: [email protected]

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

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

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

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: [email protected]

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.

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 2 CFR Part 200.