This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

RFA-OD-25-008: Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

• National Institutes of Health (NIH)
• U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

• NATIONAL INSTITUTES OF HEALTH (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute on Drug Abuse (NIDA)
  • National Cancer Institute (NCI)

Funding Opportunity Title Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)

Activity Code

• R03
• Small Grant Program

Announcement Type New

Related Notices

• February 27, 2026 - Notice of Information Encouraging Submission of Pre-Application Consultation Information for RFA-OD-25-008, "Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)". See Notice NOT-OD-26-045.
• April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON) RFA-OD-25-008

Companion Funding Opportunity None

Number of Applications See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.077

Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.

The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Funding Opportunity Goal(s) The overall goals of this NOFO will help provide the scientific evidence to inform the implementation of the Family Smoking Prevention and Tobacco Control Act, which provides FDA CTP the authority to regulate tobacco product manufacturing, distribution, and marketing.

Key Dates

• Posted Date: June 24, 2025
• Open Date (Earliest Submission Date): October 18, 2025
• Application Due Dates:
  • New: November 18, 2025
  • Renewal / Resubmission / Revision (as allowed): November 18, 2025
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable
• Review and Award Cycles:
  • Scientific Merit Review: February 2026
  • Advisory Council Review: May 2026
  • Earliest Start Date: July 2026
• Next Cycle Due Dates:
  • New: July 14, 2026
  • Renewal / Resubmission / Revision (as allowed): July 14, 2026
  • AIDS - New/Renewal/Resubmission/Revision, as allowed: Not Applicable
  • Scientific Merit Review: October 2026
  • Advisory Council Review: January 2027
  • Earliest Start Date: April 2027

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. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date: July 15, 2026

Due Dates for E.O. 12372: Not Applicable

Required Application Instructions 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.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• 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.
• 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 New Investigators (including Early-Stage Investigators and investigators who have not successfully competed for independent NIH funding) in the biomedical, behavioral, and social sciences who are in the early stages of establishing independent careers in tobacco regulatory research but have not yet received any grant to support research in tobacco regulatory science. Through the NIH TRSP partnerships, we will solicit applications for R03 grants to support “small research projects that can be carried out in a short period of time with limited resources.” The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Applicants are encouraged to conduct projects that ultimately have potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.

The awards under this NOFO will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research findings generated from this NOFO are expected to provide sufficient preliminary data for subsequent investigator-initiated research that is relevant to the FDA's regulation of tobacco products to protect public health. The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulatory science within the framework of the FSPTCA.

Background Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products including electronic nicotine delivery systems or ENDS (e.g., vapes, disposable vapes, vape pens, electronic cigarettes (e-cigarettes or e-cigs), nicotine pouches, cigars, pipe tobacco, heated tobacco products that do not meet the definition of cigarette, hookah (waterpipe) tobacco, and future tobacco products. Tobacco products are subject to provisions outlined in the FD&C Act. FDA also has the authority to develop tobacco product standards, when appropriate for the protection of public health.

A full description of the FSPTCA can be found at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-table-contents

Program Scope and Research Objectives The FDA and NIH share interest in supporting research that could inform FDA's tobacco regulatory authorities. To that end, the new high-priority research encouraged by this NOFO is expected to provide additional scientific data to inform regulation of tobacco products to protect public health. Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, the new high-priority research will provide additional science for the FDA to consider as it implements the FSPTCA.

Projects must propose high-priority research aims that are within the regulatory authority of FDA CTP and one or more of the High-Priority Research Topic(s) identified in this NOFO in order to be considered responsive to this NOFO. As such, investigators are strongly encouraged to discuss whether their application is responsive to this NOFO with a Scientific/Research Contact listed in Section VII before submitting their Letter of Intent and/or application and to review the Frequently Asked Questions document.

HIGH-PRIORITY RESEARCH TOPICS

High-Priority Research Relevant to Addiction Understanding the effect of tobacco product characteristics* of ENDS and/or nicotine pouches on addiction and/or abuse liability across populations. Applications addressing addiction must (1) focus on ENDS and/or nicotine pouches AND (2) address one or more of the high-priority research topics below:

• Correlation of nicotine pharmacokinetic and/or pharmacodynamics (and/or other abuse liability outcomes including liking, craving, and withdrawal symptoms) of ENDS and/or nicotine pouches with use behaviors, including cessation or substitution of combusted cigarettes;
• Impact of changes in tobacco product characteristics* of ENDS and/or nicotine pouches on dependence and/or use behaviors including progression to regular use.

High-Priority Research Relevant to Behavior Understanding the knowledge, attitudes, perceptions, and/or behaviors related to use of ENDS, heated tobacco products, nicotine pouches and/or other emerging tobacco products and/or the impact of characteristics* of these products on use behaviors of these products across populations, when appropriate to the research question. Applications addressing behavior must address the high-priority research topic below:

• The impact of ENDS, heated tobacco products, nicotine pouches and/or other emerging tobacco products characteristics* on tobacco product use behaviors (such as experimentation, initiation, progression, dual/poly tobacco use, switching, and/or cessation-related behaviors) among youth, young adults, and/or adults.

High-Priority Research Relevant to Health Effects Understanding the health effects of ENDS in human subjects. Applications addressing health effects must address the high-priority research topic below:

• Impact of ENDS use on human health, limited to cardiovascular effects, pulmonary effects, or neurological effects, including acute and/or chronic health outcomes in human subjects (i.e., not animal models).

High-Priority Research Relevant to Product Composition and Design Understanding the chemical and/or microbial constituents in any tobacco products and/or the methods for measuring them across products with diverse characteristics* including impacts due to design properties. Applications addressing product composition and design must address one or more of the high-priority research topics below:

• Determination of the concentration of propylene glycol where there will be an impact on microbial growth in tobacco filler of cigars, pipe, or waterpipe.
• Determination of variability of nicotine pouch product characteristics and impact on nicotine delivery.

High-Priority Research Relevant to Toxicity Understanding how ENDS and/or changes to ENDS characteristics* affect their potential to cause morbidity and/or mortality in users through direct exposure and/or in nonusers through secondary exposure. These could include cell culture (in vitro) models, animal (in vivo) approaches, computational (in silico) methods, and/or other alternative toxicology approaches, and/or studies that test the toxicity of ENDS aerosols (e.g., aldehydes, metals), or specific constituents (e.g., aldehydes, metals) in ENDS. Applications addressing toxicity must (1) focus on ENDS and/or their characteristics* AND (2) address the high-priority research topic below:

• Generate in vitro dose-response bacterial mutagenicity data that can be used to identify hazard and characterize benchmark concentration (BMC) and point of departure (PoD) for ethyl maltol and/or maltol.

*The term characteristic encompasses materials, ingredients (including additives, nicotine formulations, nicotine concentration, and flavors), design, composition, heating source, nicotine flux, and other features of a tobacco product, including harmful and potentially harmful constituents. Packaging is not included in this definition of characteristic. Characteristics of explicitly specified tobacco products can be incorporated into all of the above high-priority research topics.

POPULATIONS EXPERIENCING TOBACCO-RELATED DISPARITIES Where appropriate to the research question, applications may focus on populations or groups that bear disproportionate burden of tobacco product risk and harm. If a population experiencing tobacco-related disparities will be included, applicants will be expected to identify the population and how the population is important to the research question, considering the impact on population health.

NON-RESPONSIVE RESEARCH TOPICS Projects must propose research aims that are within the regulatory authority of FDA CTP and the High-Priority Research Topics identified in this NOFO in order to be considered responsive to this NOFO. As such, investigators are strongly encouraged to discuss whether their application is responsive to this NOFO with a Scientific/Research Contact listed in Section VII before submission of their Letter of Intent and/or application and to review additional information available, including research priorities and a Frequently Asked Questions document.

Only High-Priority Research Topics listed above will be deemed responsive. Although the following research topics may be within FDA CTP’s regulatory authorities to fund, they are not to be included in the NOFO and will be deemed non-responsive:

• Investigations of tobacco products other than those explicitly specified in the high-priority research topics of this RFA
• Studies exploring how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media
• Studies exploring the impact of marketing on susceptibility to and initiation of using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation, regular use, product switching, dual use, and cessation-related behaviors among different populations
• Studies of the potential or actual impact of FDA regulatory actions
• Mechanistic studies (i.e., basic science of disease development) unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome
• Short-term studies of the acute effects of reduced nicotine content cigarettes
• Studies identifying biomarkers of secondary and tertiary exposure to tobacco products
• Studies of in-utero exposure to tobacco products and subsequent behavioral effects in offspring
• Studies using neuroimaging as a biomarker of tobacco product exposure or nicotine dependence
• Studies identifying epigenetic biomarkers associated with tobacco use including DNA methylation or other non-DNA sequence related mechanisms that regulate gene expression through reversible alterations such as histone modification and noncoding RNA modulation

SPECIAL CONSIDERATIONS Applicants should keep the following special considerations in mind as they prepare their applications:

• Data Harmonization for Tobacco Regulatory Research via the PhenX Toolkit: NIH and FDA encourage investigators conducting human-subjects studies to incorporate measures from the PhenX Toolkit (www.phenxtoolkit.org), including measures from the Tobacco Regulatory Research Collections. The PhenX Toolkit provides standard measures for inclusion in human subjects research to enable sharing, comparing, and combining of data and results.
• Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this NOFO. The National Advisory Council on Drug Abuse (NACDA) has set forth points with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. This includes any consulting relationships (paid or unpaid) with the tobacco industry or organizations supported in whole or in part by this industry. Please see (https://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-tobacco-industry-funding-nida) for details. While this guidance was originally issued for NIDA applicants, it is relevant for all applications submitted under this NOFO.
• Recommended Guidelines for the Administration of Drugs to Human Subjects: NACDA also recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at https://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.
• 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

Funding Instrument Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

• New
• Resubmission

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial? Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIH, with support from the FDA Center for Tobacco Products (CTP), intends to fund up to 4 R03s, corresponding to a total of up to $500,000 for fiscal year 2026. Future year amounts will depend on fund availability.

Award Budget Application budgets are limited to $75,000 in direct cost per year.

Award Project Period The maximum project period is 2 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

• Higher Education Institutions - Includes all types
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
• 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
• 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

Foreign 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.

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply-Application Guide.

Only New Investigators (including Early-Stage Investigators and investigators who have not successfully competed for independent NIH funding) who fit the criteria in this section are eligible to apply to this NOFO.

However, this NOFO excludes from consideration individuals who have received any Research Project (R01) from any NIH Institute or Center as well as individuals who have received any award through the FDA CTP such as a Small Grant Program Award (R003) or an Exploratory/Developmental Research Grant Award (R21) funded through the FDA CTP or are in the Research Award Phase of a Pathway to Independence Award (R00) funded by the FDA CTP.

Investigators who have questions about eligibility should contact the Scientific/Research Contact listed in Section VII. Agency Contacts.

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.

Instructions for Application Submission 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.
• 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.
• 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:
  • 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.
    • The research findings generated from this Notice of Funding Opportunity (NOFO) may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If the research data are cited publicly in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in 2 CFR 200 (http://gpo.gov/fdsys/pkg/CFR-2015-title2-vol1/pdf/CFR-2015-title2-vol1-part200.pdf) and the NIH Grants Policy Statement (https://grants.nih.gov/policy-and-compliance/nihgps).
• 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.

7. Other Submission Requirements and Information

• 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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by FDA and components of participating organizations, NIH. Applications that are incomplete or non-compliant, nonresponsive to one or more of the High-Priority Research Topic(s) identified in this NOFO, and/or proposing work outside FDA-CTP's regulatory authority will not be reviewed.

In order to expedite review, applicants are requested to notify the Tobacco Regulatory Science Program by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and application title.

Mandatory Disclosure 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. Any instructions provided here are in addition to the instructions 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.

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

Overall Impact Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following 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.

Scored Review Criteria 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.

• Factor 1. Importance of the Research (Significance and Innovation)

  • Significance: Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance. Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.
  • Innovation: Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

• Factor 2. Rigor and Feasibility (Approach)

  • Approach: Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).
    • Rigor: Evaluate the potential to produce unbiased, reproducible, robust data. Evaluate the rigor of experimental design and whether appropriate controls are in place. Evaluate whether the sample size is sufficient and well-justified. Assess the quality of the plans for analysis, interpretation, and reporting of results. Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting. For applications involving human subjects or vertebrate animals, also evaluate:
      • the rigor of the intervention or study manipulation (if applicable to the study design).
      • whether outcome variables are justified.
      • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
      • whether the study population appropriately models the target population. For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.
    • Feasibility: Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances. For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex. For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

• Factor 3. Expertise and Resources (Investigator(s) and Environment)

  • Investigator(s): Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
  • Environment: Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria 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.

• Protections for Human Subjects: For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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 categories of research that are exempt under 45 CFR Part 46, 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.
• Vertebrate Animals: When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
• Biohazards: When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
• Resubmissions: As applicable, evaluate the full application as now presented.
• Renewals: As applicable, evaluate the progress made in the last funding period.
• Revisions: As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

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

• Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support: Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, 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.

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

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:

• 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.

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).
• Milestones: Future support of a study funded under this NOFO is contingent upon adequate participant recruitment based on projected milestones.
• Investigational Tobacco Products: Currently there are no federal regulations regarding clinical research involving the use of investigational tobacco products. The Draft Guidance on Use of Investigational Tobacco Products describes the Agency’s current thinking regarding the definition of investigational tobacco product and the kinds of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective. In addition, FDA has provided information regarding research to be conducted using newly deemed tobacco products in Guidance for Industry Investigational Use of Deemed Finished Tobacco Products that were on the U.S. Market on August 8, 2016, during the Deeming Compliance Periods.

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.
• 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.

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:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• 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.

Cooperative Agreement Terms and Conditions of Award Not Applicable

3. Data Management and Sharing 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.

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.

Application Submission Contacts

• 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]

Scientific/Research Contact(s)

• Maria L. Roditis, PhD, MPH National Cancer Institute (NCI) Telephone: 240-276-5518 Email: [email protected]
• Qing Lu, DVM, PhD National Heart, Lung, and Blood Institute (NHLBI) Telephone: 301-480-9158 Email: [email protected]
• Flair Lindsey National Institute on Drug Abuse (NIDA) Telephone: 301-827-5783 Email: [email protected]

Peer Review Contact(s)

• Center for Scientific Review (CSR) Email: [email protected]

Financial/Grants Management Contact(s)

• Crystal Wolfrey National Cancer Institute (NCI) Telephone: 240-276-6277 Email: [email protected]
• Francesca Hunter National Heart, Lung, and Blood Institute (NHLBI) Telephone: 301-402-3127 Email: [email protected]
• Amy Bucheimer National Institute on Drug Abuse (NIDA) Telephone: 301-827-6694 Email: [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.

Authority and Regulations Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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