Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional) RFA-OD-25-008 is sponsored by Food and Drug Administration (FDA) and National Institutes of Health (NIH). This Notice of Funding Opportunity supports new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research.

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) 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) Companion Funding Opportunity See Part 2, Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 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.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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). 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. Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information 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 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.

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

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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

U.S. Territory or Possession 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 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 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 (R03) 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. 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 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. 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.

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

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.

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.

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. 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. 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 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