It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Pre-Application Webinar

The NIH anticipates holding a pre-application web-based teleconference to which all interested prospective applicants are invited. NIH Program and Review and FDA CTP staff persons will explain the goals and objectives of the funding opportunity announcement (FOA), discuss the application peer review process, and answer questions. Information about this pre-application conference call will be available at (https://prevention.nih.gov/tobacco-regulatory-science-program).

Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications for a Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science. The overall objective of CASEL is scientific coordination and logistics and operations management of research projects and programs that can inform the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) in its tobacco product regulatory activities. Through leadership, coordination, and facilitation of communication and collaborative efforts among tobacco regulatory science investigators, CASEL can accelerate the identification, integration, and advancement of research findings relevant to the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

CASEL project coordination and data synthesis will focus on the research programs funded by the FDA CTP including the grant portfolio of the NIH Tobacco Regulatory Science Program (TRSP), (https://prevention.nih.gov/tobacco-regulatory-science-program/funded-research-tobacco-regulatory-science-program?f%5B0%5D=tcors_type%3A386) as well as research supported via the Centers for Disease Control and Prevention, other FDA Centers, and research contract organizations (see http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/Research/ucm396257.htm for CTP-supported Tobacco Regulatory Research Projects). The overarching objective of the CTP-funded research program is to conduct research that will inform tobacco product regulatory activities and address the research priorities related to the regulatory activities of the FDA CTP. CASEL, in conjunction with the NIH and the FDA CTP, will facilitate communication, scientific coordination and collaboration among the CTP-funded research programs. CASEL will 1) provide logistical support and coordination across CTP-funded research, 2) conduct scientific synthesis and facilitate collaborative research, including support for projects that address the high priority, time-sensitive needs of the FDA CTP 3) facilitate career enhancement of tobacco regulatory scientists and 4) support dissemination of research results.

The award made under this FOA will be administered by the NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The research coordinated by CASEL is expected to generate additional scientific evidence that the FDA CTP can use to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Background

Role of the FDA in the Family Smoking Prevention and Tobacco Control Act (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, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), and e-pipes), cigars, pipe tobacco, gels, 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-overview

Partnership between the FDA and the NIH in the Context of the FSPTCA

Within the framework of the FSPTCA, the NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. These activities are coordinated by the FDA CTP and by the Tobacco Regulatory Science Program (TRSP) in the Office of Disease Prevention (ODP) at the NIH. The FDA and the NIH share an interest in supporting research that could inform the development and evaluation of tobacco product regulatory activities and actions. To that end, the research supported through TRSP and other CTP-funded research is expected to contribute a science base to inform the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. Consistent with the FDA CTP mission, this FOA seeks CASEL applications that coordinate research across seven research areas, as noted below.

FDA Center for Tobacco Products Research Areas

CASEL will provide coordination and facilitation of tobacco regulatory science across the FDA CTP-funded research program. The scope of the CTP-funded research program focuses on the following priority areas:

• Product Composition and Design Understanding the chemical constituents in tobacco products and the methods for measuring them across products with diverse characteristics*.
• Toxicity Understanding how tobacco products and changes to tobacco product characteristics* affect their potential to cause morbidity and mortality in users and nonusers through secondary exposure; including animal (in vivo) and cell culture (in vitro) models, as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke (other than cigarette), aerosols, or specific constituents in tobacco and the tobacco product.
• Addiction Understanding the effect of tobacco product characteristics* on addiction and abuse liability across populations.
• Health Effects Understanding the short- and long-term health effects of tobacco products (excluding conventional cigarettes) with priority on longitudinal data. Areas of interest include cardiovascular, cancer, neurological (e.g., seizures), oral, reproductive, and respiratory health effects (including inflammation and lung disorders (e.g., asthma, COPD)).
• Behavior Understanding the knowledge, attitudes, perceptions, and behaviors related to tobacco product use and the impact of tobacco product characteristics* on behaviors across populations, as appropriate.
• Communications Understanding how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media.
• Marketing Influences Understanding 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. Topics may include marketing such as advertising, digital media, and promotions.
• Impact Analysis Understanding the potential or actual impact of FDA regulatory actions.
• *The term "characteristic" encompasses materials, ingredients (including additives, nicotine formulations, and flavors), design, composition, heating source, and other features of a tobacco product, including harmful and potentially harmful constituents. Product characteristics can be incorporated into all the above topics.

All work proposed by or through CASEL must be within scope of the regulatory authority of the FDA CTP in order to be considered responsive to this FOA.

Applications that are incomplete and/or nonresponsive will not be reviewed. As such, investigators are strongly encouraged to discuss whether their application is suitable for this FOA with a Scientific/Research Contact, listed in Section VII, prior to submission of their application. Additional information, including research priorities and a Frequently Asked Questions document can be found at: https://prevention.nih.gov/sites/default/files/2021-05/GeneralResponsiveness-FAQs_508.pdf.

Objectives and Scope

CASEL is expected to provide scientific coordination for the broad portfolio of tobacco regulatory research being funded by FDA CTP to inform their regulatory activities to reduce tobacco-related disease, disability, and death in the United States. In cooperation with NIH and FDA CTP, CASEL will help to build a broad base of knowledge and resources for the advancement, dissemination and translation of tobacco regulatory science. Key goals will be to provide leadership in fostering excellence in tobacco regulatory research and supporting career enhancement efforts in tobacco regulatory science.

CASEL will be expected to provide intellectual and scientific leadership as well as logistical support infrastructure for the entire FDA CTP-funded research program. CASEL will encourage and support research networks among FDA CTP-funded tobacco regulatory scientists that foster communication, collaboration, and research that address FDA CTP s scientific priorities. CASEL also will have an important role in coordinating research generated by the Tobacco Centers of Regulatory Science (TCORS) RFA-OD-22-004, including the TCORS career enhancement activities, and in enabling collaboration among other FDA CTP-funded recipients and investigators conducting tobacco regulatory research.

CASEL will work with the FDA CTP-funded researchers, NIH and FDA CTP scientific, administrative, and program staff (Federal partners) to bring together expertise and data relevant to the funded research programs. CASEL must demonstrate the ability to provide scientific leadership to integrate activities of the awarded research projects so as to minimize duplication, maximize the use of existing resources, establish new resources when necessary to facilitate collaboration, data synthesis, integration, and the dissemination of research findings and outcomes.

Required Structure and Main Components of CASEL:

All CASEL applicants must fulfill the following main aspects for the proposed CASEL.

1) Leadership and Logistics Core - CASEL must be able to provide close coordination of research efforts across the FDA CTP-funded research program. This role will require strong leadership, scientific insight, capacity to bring diverse teams together and ability to provide the logistical skills needed to support a large, multi-agency research portfolio.

Overall Program

• Establish a CASEL Steering Committee, including representation from NIH, FDA CTP, and currently funded research investigators to guide CASEL activities and ensure communication across the FDA CTP-funded research program.
• Provide scientific leadership to facilitate and support communications among FDA CTP-funded research recipients and NIH and FDA CTP scientific, administrative, and program staff.
• Create and manage relevant logistical infrastructure to plan and support all meetings, including grantee conference calls and/or web-based meetings, career enhancement symposia, and meetings of working groups and committees. A key requirement for CASEL is to plan, coordinate, convene and fund a minimum of two scientific meetings per year among TCORS grantees and/or all CTP-funded researchers, as well as meetings to address timely topics of interest to FDA CTP and the research community.
• Develop and maintain a website or other shared workspace to facilitate communication and collaboration among FDA CTP-funded researchers.
• Create systems and maintain an ability to communicate rapidly and efficiently with investigators funded through the entire FDA CTP-funded research program.
• Work with NIH and FDA CTP to establish protocols for ensuring non-disclosure and confidentiality of research presented in shared workspace, as applicable (e.g., websites, meetings, pre-publication data).

TCORS

• Establish and maintain support for a TCORS Steering Committee to include TCORS principal investigators and representation from NIH and FDA CTP.
• In collaboration with the TCORS Steering Committee and Federal partners, develop standard operating procedures for the TCORS.
• Create and manage relevant logistic infrastructure to plan and support TCORS conference calls and/or web-based meetings, career enhancement symposia, meetings of the TCORS Steering Committee and other TCORS working groups and committees.

2) Analysis and Rapid Response Core - This Core will provide an overview ("big picture approach") of the CTP-funded research program to foster collaboration and enable identification of research needs, gaps and opportunities for coordination, collaboration, and synthesis. This role will require understanding the breadth of tobacco regulatory research and the ability to identify and facilitate timely pursuit of pressing research gaps and emerging, time sensitive topics in collaboration with federal partners. This Core will also support the use of common study variables, methods, and protocols among CTP-funded projects to facilitate future analyses of aggregated data. This may include: the identification of one or more data sharing repositories, the creation of a tobacco regulatory science ontology for FDA CTP-funded data and outcomes, facilitation of data and resource sharing for secondary analysis, and efficient searching and quick access to publications and other products created through FDA CTP-funded awards. The Core will facilitate use of the Tobacco Regulatory Research consensus measures available in the PhenX Toolkit (www.phenxtoolkit.org) for inclusion in human subjects research to enable sharing, comparing, and combining of data and results. Using common measures will also assist program assessment of scientific progress in the field, identification of new research opportunities, and formation of collaborations to promote discovery and to resolve areas of scientific controversy. The CASEL will facilitate these collaborations in conjunction with NIH and FDA CTP scientific, administrative, and program staff.

This Core will serve as the organizational hub for an Opportunity Fund (OF) that will support time-sensitive, rapid response projects to which extramural investigators may apply. The OF will be made available each year to support projects that address the high priority, time-sensitive research needs of the FDA CTP. CASEL will set aside $1,500,000 of its direct costs per year to award subcontracts for this purpose. Duties for managing this fund include:

• Establishing an administrative structure to solicit, review, award and track project applications submitted to the OF
• Establishing an Executive Committee of designated NIH and FDA CTP Scientists to:
  • o Provide overall OF oversight
  • o Specify time-sensitive research questions
  • o Identify the appropriate applicant pool based on expertise required to address research questions
  • o Identify Federal partners as Subject matter Experts (SMEs) for application review
• Disbursing and tracking OF funds with collaboration from the Executive Committee
• Implementing plans for communication with OF recipients regarding progress and reporting of findings.
• Establishing procedures, formats, and timelines for reporting on the review of progress and findings of OF projects and expenditures to the OF Executive Committee

It is expected that this Core will solicit OF applications no more than 4 times per year. The OF will support projects for up to 12 months.

3) Career Enhancement Core- The CASEL will take a leadership role in coordinating, organizing and integrating the career enhancement activities across the TCORS research centers and with other FDA CTP-funded recipients. It will support continuing education in tobacco regulatory science among tobacco regulatory science investigators. The goal is to aid in the development of a cadre of tobacco regulatory scientists and a program to disseminate research findings and data sharing. Such career enhancement should expose investigators to the multiple research topics pertaining to tobacco regulation. Because tobacco research scientists are widely dispersed by geography and discipline, this type of career enhancement is more difficult to obtain. CASEL is strongly encouraged to create collegial and collaborative networks among the FDA CTP-funded recipients and investigators who are conducting research in tobacco regulatory science.

4) Dissemination Core - CASEL must enable dissemination of research outcomes to appropriate audiences.

• Develop and maintain a website for the purposes of sharing and disseminating information to appropriate audiences about research projects, career enhancement materials and research findings. It is expected that the website will offer protected levels of access to different users (e.g., TCORS-only access, all FDA CTP-funded investigator access, trainee access and public access).
• Consolidate data and facilitate dissemination of results across multiple venues, including scientific reports, workshops, seminars, websites, meetings, conferences, collaborative manuscripts and special and/or themed journal issues. Develop and disseminate synopses of these efforts.
• Coordinate timely review and editing of collaborative tobacco regulatory science papers or reports.
• Inform CTP-funded researchers of relevant issues that may impact their research, including but not limited to updates to policy and regulation of tobacco and information in the media.
• Create and maintain comprehensive bibliography of grantee publications
• Develop materials for dissemination of research outcomes (e.g., slides, fact sheets, infographics)

Governance of CASEL

The Federal partners will work collaboratively with the CASEL recipients on developing procedures and management protocols, monitoring study progress, ensuring disclosure of conflicts of interest and adherence to FDA and NIH policies, and participating in data analysis and manuscript preparation as appropriate.

CASEL will be governed by a CASEL Steering Committee, to be established. The Steering Committee will advise the PD/PI and oversee the activities of CASEL, including the policies, procedures, and strategies that pertain to its work with the TCORS and other FDA CTP-funded research programs. These activities include but are not limited to encouraging collaboration and pursuit of priority research topics and coordinating and facilitating career enhancement and educational programs. The Steering Committee will have the ability to establish sub-committees to advise the larger Steering Committee. The CASEL Steering Committee will work collaboratively across its membership, comprised of representatives of CASEL (PD(s)/PI(s)), FDA CTP-funded PD(s)/PI(s), and NIH and FDA CTP scientific staff. The Steering Committee will also work collaboratively with any established sub-committees and working groups. The Steering Committee will identify and develop opportunities for initiatives and projects that capitalize on unique strengths and expertise of the FDA CTP-funded tobacco regulatory science program, and that address the research needs of FDA CTP. Examples of initiatives include, but are not limited to, time-sensitive research opportunities, career enhancement activities, white papers, topics for annual scientific meetings, and website development and other dissemination activities.

Special Considerations

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

• Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this RFA.
• 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. 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 RFA.
• All participants at grantee meetings may be required to sign a non-disclosure agreement of non-public information presented and discussed and all participants may be required to provide financial disclosure that will be included in participant information.

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Note: Applicant institutions may submit multiple applications in response to this FOA and RFA-OD-22-004 (TCORS) and RFA-OD-22-002 (CRST). Key personnel of CASEL recipient team, however, cannot include key personnel from the research team of a TCORS nor CRST recipient.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are strongly encouraged to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Tobacco Regulatory Science Program
Office of Disease Prevention
Telephone: 301-451-7464
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall (use for overview of the proposed Center)	12
Admin Core (use for Leadership and Logistics Core)	6
Analysis (use for Analysis and Rapid Response Core)	6
Career Enhancement (use for Career Enhancement Core)	6
Dissemination Core (use for Dissemination Core)	6
Center-Named Core (use for Center-Named Core(s))	6

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Leadership and Logistics Core: maximum of 1 required
• Analysis and Rapid Response Core: maximum of 1 required
• Career Enhancement Core: maximum of 1 required
• Dissemination Core: maximum of 1 required
• Center-Named Core(s): optional

When preparing your application, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: The Specific Aims for the Overall Component must be the overall vision for the Center. These Specific Aims should not be the same as the specific aims of the other components, but should be overarching and at a high level.

Research Strategy: Provide a concise description of the vision and proposed plan for the Center. Explain how the CASEL cores, including key personnel, will interact, how their activities will contribute to the accomplishment of the overall Center goals, and how the organization of the components into a Center will create an entity that will result in a useful and important resource for the greater tobacco regulatory research community.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Core Lead should possess strong leadership, scientific insight, capacity to bring diverse teams together, and expertise in the art and science of organization and management of science teams

Budget forms appropriate for the specific component will be included in the application package.

All costs associated with the Leadership and Logistics Core should be included in the budget. This includes but is not limited to costs associated with: planning and convening topical workshops, an annual TCORS grantee meeting, annual scientific meetings, and communication tools for cross-site communication.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the specific aims of the Leadership and Logistics core, including strategies to coordinate research across the CTP-funded research program and provide the logistical infrastructure to support a large, multi-agency research portfolio.

Research Strategy: This section should include a description of the structure of the Center, including a brief management plan and organization chart with the role of the Leadership and Logistics Core defined. The CASEL must be able to support and coordinate the efforts of investigators and research programs in tobacco regulatory science, and in particular provide close coordination of functions of TCORS are provided in RFA-OD-22-004. Describe how this role will be fulfilled, including strategies for connecting with other existing research initiatives and data resources outside of TCORS program (e.g., the PATH Study, CTP-funded NIH extramural and intramural research grants, and CTP-funded projects via other federal partners and research contract projects).

Because of the program requirement for interactions across research centers and projects, applicants must articulate how the CASEL Leadership and Logistics Core will operationalize the following activities:

a) Providing scientific leadership and serving as an intellectual/scientific hub for the TCORS Research Centers, and the broader CTP-funded research program

b) Providing leadership for the Steering Committee and helping to bring together appropriate experts to advise Steering Committee members

c) Establishing and providing scientific expertise and support to create topical Special Interest and Working Groups (e.g., groups focused on addressing toxicity of tobacco products, health effects of tobacco product use, or the influence of tobacco marketing on behavior) relevant to the CTP-funded research programs and scientific needs

d) Facilitating and mediating contacts between recipients and the NIH and the FDA CTP professional staff to allow for efficient interactions, consultations, and oversight functions

e) Providing expertise and logistical infrastructure supporting TCORS research centers and facilitating trans-CTP-funded functions and activities

f) Providing expertise and logistical and administrative support for all the activities of the Steering Committee and its subcommittees, including Working Groups or other established committees

g) Providing scientific expertise and oversight for activities covered in all CASEL cores.

h) Organizing and providing logistical support for the annual meetings of TCORS investigators (in cooperation with the NIH and the CTP representatives), biennial tobacco regulatory scientific meetings, and meetings of topical scientific work groups

i) Providing and supporting state-of-the-art cross-site communication tools for TCORS and other CTP-funded recipients, which may include public and/or internal website(s), web meetings and seminars, and video-conferencing

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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 SF424 (R&R) Application Guide must be followed

Analysis and Rapid Response Core

When preparing your application, use Component Type Analysis.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

All costs associated with the Analysis and Rapid Response Core should be included in the budget. This includes but is not limited to costs associated with the Opportunity Fund to solicit, review and award Rapid Response Projects. CASEL will set aside $1,500,000 of its direct costs per year to award Rapid Response Projects.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the specific aims of the Analysis and Rapid Response Core.

Research Strategy: The Analysis and Rapid Response Core must describe how it will achieve the following activities:

a) Facilitate collaborative research and scientific integration across multiple research institutions and/or disciplines. This may include the identification of emerging, high priority topics. The expected outcome is to convene appropriate expertise to generate and address new, novel research questions and findings

b) Identify commonalities in research directions and specific questions being explored across the CTP-funded research projects to promote collaborative efforts, where appropriate, and/or reveal gaps in the research portfolio that may be addressed

c) Provide and/or identify expertise and support for TRS investigators methodologic and analytic challenges or educational opportunities, e.g., meta-analyses, secondary data analyses with publicly available datasets, and emerging analytic methods

d) Identify scientific questions in tobacco regulatory science that could be jointly explored across TCORS, and/or other CTP-funded research projects and programs

e) Provide the methodological support and expertise to facilitate cross-project data linking, integration, and harmonization, including support for the use of consensus measures, when feasible, to maximize comparison across research projects and potential pooling of data.

f) Support an Opportunity Fund to solicit, review and award time sensitive, RRP applications.

g) Facilitate rapid, coordinated data collection in response to NIH of FDA CTP requests.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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 SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type Career Enhancement

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the specific aims of the Career Enhancement Core that will facilitate and enhance investigator expertise in Tobacco Regulatory Science.

Research Strategy: CASEL must develop an infrastructure that can coordinate, organize and integrate career enhancement activities and associated resources across TCORS and other CTP-funded researchers (see https://www.fda.gov/tobacco-products/research/ctp-supported-tobacco-regulatory-research-projects)

Plans for this Core must describe approaches to the following activities, which will be conducted in collaboration with TCORS career enhancement activities:

a) Facilitating collaboration across CTP-funded recipients and TCORS career enhancement activities, including the creation of networks of tobacco regulatory scientists at various career stages.

b) Disseminating career enhancement modules and curricula in diverse disciplines and topical areas relevant to the regulatory authority of the FDA CTP (e.g., nicotine dependence thresholds, tobacco product constituents and toxicology, and smoking topography and other measurement technologies for assessment of tobacco use and dependence); this may include professional development career enhancement activities (e.g., grantsmanship, public speaking, leadership) or participating in team science activities across disciplines and settings (e.g., career enhancement in leading, managing, and participating in team science collaborations, using transdisciplinary research approaches) to support transfer of knowledge across disciplines

c) Facilitating web-based participation across CTP-funded mechanisms with career enhancement components for events such as speakers, presentations, workshops, and other educational opportunities that, for example, may be developed or hosted at one research institution and shared with others

d) Disseminating and promoting CTP-funded research findings by facilitating the organization of sessions to present TCORS career enhancement research outcomes at annual investigator meetings and relevant national meetings and conferences, actively synthesizing and disseminating relevant results, and disseminating tobacco regulatory science information to the larger tobacco control, public health, policy, and biomedical research community.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Dissemination Core

When preparing your application, use Component Type Dissemination Core

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

SF424 (R&R) Cover (Dissemination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Dissemination Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Dissemination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Dissemination Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Dissemination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Dissemination Core)

Specific Aims: Describe the specific aims of this core to disseminate research findings to appropriate audiences.

Research Strategy: Describe how CASEL will enable dissemination of research, including the following activities:

• Development and maintenance of a website for the purposes of sharing and disseminating information to appropriate audiences.
• Consolidating CTP-funded data and facilitate dissemination of results across multiple venues.
• Coordinating timely review and editing of collaborative tobacco regulatory science papers or reports.
• Informing CTP-funded researchers of relevant issues that may impact their research.
• Organizing opportunities for investigators to inform CTP and other scientists of research progress and outcomes.
• Presenting progress and outcomes of CASEL activities to appropriate audiences (e.g., scientific meetings).
• Providing comprehensive bibliography of grantee publications on a quarterly basis.
• Develop materials for dissemination of information about research program and research outcomes (e.g., slides, fact sheets, infographics).

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Dissemination Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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 SF424 (R&R) Application Guide must be followed

Center Named Core

When preparing your application, use Component Type Center Named Core

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

SF424 (R&R) Cover (Center Named Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Center Named Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Center Named Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Center Named Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Center Named Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Center Named Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Center Named Core)

Specific Aims: Describe the specific aims of the additional Center-Named Core that may be a part of the CASEL.

Research Strategy: Where justified, an application may propose shared technical, statistical and/or laboratory resources, creating a core for centralized management (e.g., data, biospecimens, etc.). The justification for the need of a core service or resource should be clearly stated, along with the scientific and technical merit of the proposed core. The function of the core and how it will serve CASEL must be described clearly. The core director(s) must be appropriately trained, qualified and well suited for the core activities proposed and must commit sufficient time and effort.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Center Named Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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 SF424 (R&R) Application Guide must be followed

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Awards funded under this FOA are not subject to SNAP authorities and do not have authority for the carryover of unobligated balances from budget period to any subsequent budget period without prior written approval from the NIH. Special reporting requirements also apply, as described in Section VI.3. Reporting

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by FDA and components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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 FOA number and title, PD/PI name, and title of the application.

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.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CASEL to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the CASEL proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important issue or a critical barrier in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge and/or technical capability be improved? How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing of tobacco products?

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

Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the CASEL proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Review Criteria for Leadership and Logistics Core

Organizational Structure

What is the quality of the organizational structure of the CASEL proposal and does this structure indicate an ability to integrate the full range of Center functions to achieve the specified goals? Is the coordination between the CASEL's Leadership and Logistics core and other cores adequate and well documented?

Leadership and Managerial Capacity

Is there evidence of strong leadership and managerial capacity to bring diverse teams together across the TCORS and other CTP-funded programs?

Is there evidence of expertise in organizational, management, and/or team sciences?

Plans for Communication and Cooperation

Are there adequate plans for communication and cooperation within CASEL and with tobacco regulatory science investigators?

Core Lead

Is/Are the Core Leads appropriately experienced in coordinating large multi-site programs and well-suited to carry out the proposed administrative, professional, and scientific leadership across the CTP-funded program? Does/do the PDs/PIs have demonstrated skill with facilitating constructive dialog among investigators with potentially disparate scientific opinions and viewpoints?

If the Core uses multiple Leads, do the investigators have complementary and integrated expertise?

Are their leadership approaches, governance, and organizational structure appropriate for the proposed CASEL? Does the proposed CASEL team demonstrate evidence for potential broad mastery of tobacco regulatory science; knowledge of investigators with content, methodological, and related disciplinary expertise; and a vision for advancing the state of tobacco regulatory science?

Leadership and Management of Logistic Support

Does the proposed CASEL demonstrate experience in and clear leadership for the provision and management of logistics support services? Do the qualifications, experience, and commitment of the logistics lead ensure he/she is well suited to provide administrative, managerial, and professional leadership within the TCORS and across the CTP-funded research programs?

Plans for Facilitation

Does the application identify an adequate plan for facilitating the Steering Committee, the NIH, and the FDA review and approval of the TCORS Rapid Response Projects to 1) ensure alignment with FDA CTP regulatory authority, and 2) provide plans for data and safety monitoring consistent with NIH DSMP policies?

Review Criteria for Analysis and Rapid Response Core

Core Lead

Does the Core Lead have the appropriate scientific, organizational and managerial expertise to facilitate trans-institutional methodologic and data analytic collaborations, as well as oversight of the Opportunity Fund for Rapid Response Projects?

Commitment of Facilitation of the Use of Standardized Measures and Collaborative Activities

Does the application describe a process for facilitating the use of standardized measures, methods, and data management whenever feasible to support data aggregation and collaborative activities across Centers?

Capacity to Coordinate Analyses

Does the proposed CASEL have the capacity to coordinate analyses of the shared data elements and/or conduct meta-analyses, systems science methodologies, or secondary data analyses?

Plan for Identifying Research Gaps and Opportunities

How well does the application propose to identify research gaps and opportunities to encourage proposals that advance tobacco regulatory science?

Plans to Establish Opportunity Fund for Rapid Response Projects

Does the application identify an adequate plan for establishing oversight of the Opportunity Fund and a feasible structure for solicitation, review and award of Rapid Response Projects?

Review Criteria for Career Enhancement Core

Career Enhancement Leadership

Does the application propose career enhancement experiences, cross-site career development, and multi-disciplinary research education, with evidence of investigators' career advancement and scientific contributions?

Plan for Career Enhancement Coordination

Does the plan for the career enhancement core to work in concert with the TCORS career enhancement activities ensure creative maximization of the potential for a shared foundation of learning and minimization of redundancies and duplicative efforts across centers?

Capacity to Develop and Implement Career Enhancement Experiences

Does the plan for career enhancement coordination demonstrate the capability and creativity to effectively develop and implement activities that support cross-site career enhancement in tobacco regulatory science?

Review Criteria for Dissemination Core

Expertise Disseminating Research Findings to Appropriate Audiences

Does the applicant demonstrate experience and skills to effectively disseminate scientific findings to multiple audiences through multiple channels of communication?

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

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

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

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

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

Not Applicable

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

Not Applicable

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.

Not Applicable

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

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

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

Awards funded under this FOA are not subject to SNAP authorities and do not have authority for the carryover of unobligated balances from budget period to any subsequent budget period without prior written approval from NIH. Special reporting requirements also apply, as described in Section VI.3. Reporting.

Recipient-selected projects, such as supporting themed journal issues, seminar series, workshops, etc. will require prior approval from the NIH and the CTP to assess responsiveness to CTP Tobacco Regulatory Authorities before any expenditure of funds and/or work on the project is initiated.

The recipient institution will provide the TRSP, NIH with written plans for projects prior to its implementation.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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 of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining objectives and approaches, planning and directing the coordinating activities of the Coordinating Center with regard to the CTP-funded research portfolio in accordance with the goals of this initiative;
• Cooperating with PDs/PIs of individual CTP-funded recipients and participating NIH and FDA staff to facilitate scientific collaboration, data sharing and reporting/dissemination;
• Collaborating on activities with the Center for Rapid Surveillance of Tobacco (CRST) (e.g., webinars) and serving on the CRST Steering Committee;
• Accepting and implementing priorities, procedures and policies agreed upon by the CASEL Steering Committee to the extent consistent with applicable grant regulations;
• Attending Investigator Meetings;
• Participating in collaborative projects

NIH and FDA staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NIH Tobacco Regulatory Science Program (TRSP) scientific staff, acting as a Project Coordinator, will have the following responsibilities reflecting substantial scientific-programmatic involvement:

• Serving as a member of the CASEL Steering Committee;
• Providing technical assistance and advice to CASEL;
• Serving as a liaison between the CASEL Steering Committee and the NIH and the FDA;
• Helping to coordinate collaborative efforts that involve multiple recipients;
• Assisting the CASEL Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action; and
• Monitoring CASEL and associated TRSP grantee activities for responsiveness to CTP regulatory authorities.

The NIH reserves the right to recommend withholding support, suspension, or termination of a U54 award for lack of progress, failure to adhere to policies established by the CASEL Steering Committee, or substantial breech to the Terms of the Award.

In addition, NIDA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Designated Food and Drug Administration (FDA) Center for Tobacco Products (CTP) scientific staff, acting as Project Coordinator, will have the following responsibilities reflecting substantial scientific-programmatic involvement:

• Serving as a member of the CASEL Steering Committee;
• Providing technical assistance and scientific input to CASEL;
• Helping to coordinate collaborative efforts that involve multiple recipients;
• Assisting the CASEL Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action; and
• Monitoring CASEL and associated TRSP grantee activities for responsiveness to CTP regulatory authorities.

Areas of Joint Responsibility include:

CASEL Steering Committee

Role:

The CASEL Steering Committee will provide input and guidance regarding CASEL activities and progress. The Steering Committee will act as the main governing board across the multiple awards and will review the development of collaborative protocols, identification and development of shared protocols and resources, and identify opportunities for sharing techniques and tools developed across the TCORS and the broader CTP-funded research programs.

The Steering Committee will:

• Advise the NIH and FDA of scientific developments and opportunities that may enhance the goals of the program
• Help to develop uniform procedures and policies for the operation of the programs under this FOA
• Serve as a venue for coordination across TCORS and the broader CTP-funded research program as it relates to advancing the field, for example by reporting progress, disseminating best practices, and collectively evaluating new procedures, resources, and technologies
• Members will be required to accept and implement policies approved by the Steering Committee

The Steering Committee may, as it deems necessary, invite additional scientific advisors to meetings at which research priorities and opportunities are discussed.

The Steering Committee will meet in person once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of the program.

Composition:

The CASEL Steering Committee for will consist of the following members:

• CASEL PI(s) or if a single PI, then a CASEL PI plus a Core Lead;
• TRSP Representative;
• FDA Representative;
• NIDA Scientific Contact;
• PI representing a TCORS; and
• PI representing a non-TCORS CTP-funded grant

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of four members will be convened. It will have four members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, one FDA CTP designee and a fourth designee with expertise in the relevant area who is chosen by the other three; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.Not Applicable

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.

A Mid-Period Progress Report (MPPR) will be due every six (6) months following the project start date, as well as the annual progress report. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The scientific summary should be a maximum of two (2) pages.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://grants.nih.gov/support/index.html(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]

Heather Kimmel, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-0036
Email: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

Amy Bucheimer
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6694
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75 and 2 CFR Part 200. The NIH and the FDA have formed an interagency partnership to foster research relevant to FDA's tobacco regulatory authorities. The award under this FOA will be administered by the NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.