NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

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).

The purpose of this funding opportunity announcement (FOA) is to solicit applications for a Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science. The overall objective of CASEL is scientific coordination, 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 scientific programs funded by the FDA CTP. These include the portfolio of the NIH Tobacco Regulatory Science Program (TRSP), such as the Tobacco Centers of Regulatory Science (TCORS) and the awardees of R-mechanism grants (http://prevention.nih.gov/tobacco/funding.aspx). Also included is other FDA CTP-funded 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 the development of 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 data integration 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)

The FSPTCA, signed by the President in June 2009, created the FDA Center for Tobacco Products and granted it authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Under the law, FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products. The law also gave FDA the ability to regulate additional tobacco products, commonly referred to as deeming them through rulemaking. A full description of the FSPTCA can be found at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm. In May 2016, FDA issued a final rule to assert jurisdiction over tobacco products not under its jurisdiction that meet the statutory definition of tobacco product , including Electronic Nicotine Delivery Systems or ENDS (e.g., e-cigarettes, vape pens), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products, but not including accessories of newly deemed products.

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 CTP-funded research program. The scope of the CTP-funded research program focuses on the following priority areas:

• Product diversity understanding the types of tobacco products and how their specific characteristics affect people's attitudes, beliefs, perceptions, and use of these products
• Addiction understanding what effect different levels of nicotine and other factors have on addiction
• Toxicity and carcinogenicity understanding how changes in tobacco products affect their potential for harm and ways to reduce that harm
• Health consequences understanding the risks of different tobacco products
• Communication finding ways to effectively convey information about the risks of using tobacco and about CTP's role in regulating tobacco products
• Marketing understanding the impact of tobacco product marketing and public education on people's attitudes, beliefs, perceptions, and use
• Economics and policy estimating the economic impact of CTP's regulations; also understanding how CTP's actions change tobacco use and illness and death from tobacco use

All work conducted 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: http://prevention.nih.gov/tobacco/.

The CASEL funded as a result of this FOA is expected to serve as the scientific research coordinator for the establishment and advancement of a broad base of tobacco regulatory research, supporting excellence in research, career enhancement, and leadership that will contribute to the science base the FDA CTP can use to inform the development of product regulatory activities and actions to reduce tobacco-related disease, disability, and death in the United States. Within this program, CASEL, in cooperation with the NIH and the FDA CTP, will serve as the coordinator and facilitator of research, building a broad base of knowledge and resources for the advancement, dissemination and translation of tobacco regulatory science.

CASEL will be expected to provide intellectual and scientific leadership as well as logistical support infrastructure for the entire CTP-funded research program. CASEL will encourage and support networks among CTP-funded tobacco regulatory scientists that foster communication, collaboration, and research that address the research priorities related to the regulatory authority of the FDA CTP. CASEL also will have an important role in coordinating and integrating the efforts of the Tobacco Centers of Regulatory Science (TCORS) to be funded under RFA-OD-17-003, including the TCORS career enhancement activities, and will enable collaboration and consultation with other CTP-funded awardees, investigators, and other experts conducting tobacco regulatory research.

CASEL will work with the CTP-funded researchers and the NIH and the FDA CTP scientific, administrative, and program staff to bring together expertise and data relevant to the funded research programs. CASEL must be able to connect and build upon available expertise and infrastructure 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 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 the NIH, the FDA and currently funded research investigators to guide CASEL activities and ensure communication across the CTP-funded research program.
• Provide scientific leadership to facilitate and support communications among CTP-funded research awardees and the NIH and the FDA CTP scientific, administrative, and program staff.
• Create and manage relevant logistic 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 as established. A key requirement for CASEL is to plan, coordinate, convene and fund two scientific meetings per year among TCORS grantees and/or all CTP-funded researchers.
• Develop and maintain a website or other shared workspace to facilitate communication and collaboration among CTP-funded researchers.
• Create systems and maintain an ability to communicate rapidly and efficiently with investigators funded through the entire CTP-funded research program.
• Work with the NIH and the FDA to establish protocols for ensuring non-disclosure and confidentiality of research presented in shared workspace, as applicable (e.g., websites, meetings and pre-publication data).

TCORS

• Establish and maintain support for a TCORS Steering Committee to include TCORS principal investigators and representation from the NIH and the FDA.
• In collaboration with the TCORS Steering Committee and Federal partners, develop standard operating procedures for the TCORS.
• In cooperation with the TCORS Steering Committee and Federal partners, establish and implement procedures for review of TCORS Rapid Response Projects.
• 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 as established.

2) Analytics and Synthesis Core - The main goals of this Core are to facilitate collaborative research, provide methodological and analytic support, and provide an overview ("big picture approach") of the CTP-funded research program to 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 pursuit of pressing research questions in collaboration with NIH and FDA CTP scientists.

Examples of some expected outcomes:

The use of common study variables, methods, and protocols among the TCORS awardees and other CTP-funded investigators is expected to facilitate future analyses of the data aggregated across the CTP-funded research program. For example, investigators may be encouraged to adopt consensus measures for nicotine dependence or the biochemical validation of smoking abstinence. Increased data harmonization and aggregation through, for example, sharing the variable naming and data coding conventions for TCORS and/or CTP-funded databases to develop common coding and naming conventions across research projects. This may include: the identification of one or more data sharing repositories, the creation of a tobacco regulatory science ontology for CTP-funded data and outcomes, facilitate data and resource sharing and secondary analysis, and efficient searching and quick access to publications and other products created through CTP-funded awards. Consensus measures will serve as a resource for the tobacco regulatory science community to enhance communication and collaboration across the CTP-funded program. They will also be critical to 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 the NIH and the FDA CTP scientific, administrative, and program staff.

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 CTP-funded awardees; and 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 issues that address tobacco regulation. Because tobacco research scientists are widely dispersed by geography and discipline, this type of career enhancement has been difficult to obtain. CASEL is strongly encouraged to create collegial and collaborative networks among the CTP-funded awardees 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 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.
• 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.

Governance of CASEL

The NIH and FDA CTP scientific, administrative, and program staff will work collaboratively with the CASEL awardees 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 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)), CTP-funded PD(s)/PI(s), and the NIH and the 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 CTP-funded tobacco regulatory science program, and that address the research needs of the 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:

• Data Harmonization for Tobacco Regulatory Research via the PhenX Toolkit: NIH and FDA encourage investigators involved in human-subjects studies to consider a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Tobacco Regulatory Research Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-OD-17-034 for further details.
• 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 in response to this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Note: Applicant institutions may submit multiple applications in response to this FOA and RFA-OD-17-003 (TCORS). Key personnel of CASEL awardee team, however, cannot include key personnel from the research team of a TCORS awardee.

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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
Fax: 301-480-2230
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall (use for overview of the proposed Center)	12
Admin Core (use for Leadership and Logistics Core)	6
Analytics (use for Analytics and Synthesis Core)	6
Career Enhancement (use for Career Enhancement Core)	6
Dissemination Core (use for Dissemination Core)	6
Center-Named Core (use for Other 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
• Analytics and Synthesis Core: required
• Career Enhancement Core: required
• Dissemination Core: required
• Center-Named Core(s): optional

When preparing your application in ASSIST, 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:

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

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

When preparing your application in ASSIST, 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-17-003. 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 expertise and support to create topical Working Groups (e.g., e-cigarette working group, a mathematical or computational modeling working group, or a specimen collection and biomarkers working group) relevant to the CTP-funded research programs and scientific needs

d) Facilitating and mediating contacts between awardees 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) Organizing and providing logistical support for the annual meetings of TCORS investigators (in cooperation with the NIH and the CTP representatives), annual tobacco regulatory scientific meetings, and meetings of topical scientific work groups

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

i) Coordinating and/or facilitating development and review of specific collaborative time-sensitive research proposals.

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:

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 Inclusion Enrollment Report (Leadership and Logistics Core)

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

When preparing your application in ASSIST, use Component Type Analytics.

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

SF424 (R&R) Cover (Analytics and Synthesis Core)

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.

Research & Related Other Project Information (Analytics and Synthesis 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) (Analytics and Synthesis 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 (Analytics and Synthesis Core)

• 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.

Budget (Analytics and Synthesis 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 (Analytics and Synthesis Core)

Specific Aims: Describe the specific aims of the Analytics and Synthesis Core.

Research Strategy: The Analytics and Synthesis 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, adoption, and support for the use of consensus measures, when feasible, to maximize comparison across research projects and potential pooling of data. The expected outcome of this effort is to generate increased research collaborations and the generation of 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) Conduct and/or provide expertise and support for meta analyses, secondary data analyses, data integration, and methodology/approaches

d) Identify data to inform mathematical or statistical models and system science approaches that inform the regulatory decisions relevant to the CTP

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

f) Provide the methodological support and expertise to facilitate cross-project data linking, integration, and harmonization

g) Support cross-center resource-development projects (e.g., evaluate common measures, or develop new methodologies that can be validated at multiple centers and in larger populations, etc.)

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

i) Map the CTP-funded portfolio to CTP research priorities in order to facilitate identification of research questions for TCORS Rapid Response Projects

It is expected that this Core will strongly involve resources and personnel at individual TCORS research centers. Data management functions will involve, as appropriate, a distributed model, e.g., without having to centralize all data to one repository site. As such, the CASEL will establish and operate a Data Coordination Committee to include the NIH and the FDA CTP staff, and investigators from the CASEL, the TCORS and other selected CTP-funded programs that will advise the establishment of sharing standards, resources, and repositories; and will evaluate requests for data access from investigators outside of established CTP-funded investigator networks. Applications should describe possible plans for how such a committee would be formed and propose how the group would work. Standards for common data systems and future data repositories should be addressed within the Data Coordination Committee. Consistent with ongoing data-harmonization efforts that promote the use of common measures (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html), the CASEL must aim to achieve compatibility with shared resources like the measures from the Substance Abuse and Addiction Collection of the PhenX Toolkit (http://www.phenxtoolkit.org) or data- and publication-sharing repositories (http://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html) like the Neuroscience Information Framework (NIF, http://www.neuinfo.org/).

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:

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 Inclusion Enrollment Report (Analytics and Synthesis Core)

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

When preparing your application in ASSIST, use Component Type Career Enhancement

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

SF424 (R&R) Cover (Career Enhancement 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 (Career Enhancement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Career Enhancement 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) (Career Enhancement 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 (Career Enhancement)

• 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.

Budget (Career Enhancement 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 (Career Enhancement Core)

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 http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/Research/ucm396257.htm for CTP-supported research).

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 awardees 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.

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

PHS Inclusion Enrollment Report (Career Enhancement Core)

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

When preparing your application in ASSIST, 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 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.

Budget (Dissemination Core)

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

All costs associated with the Dissemination Core should be included in the budget. This includes but is not limited to costs associated with consolidating and facilitating dissemination of results across multiple venues such as special/themed journal issues, reports, meetings, seminars, and websites.

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).

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:

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

When preparing your application in ASSIST, 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)

Describe the specific aims of the additional Center-Named Cores that may be a part of the TCORS. Each Center-Named Core must have a separate specific aims page. 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)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• 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.

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.

Letters of Support: Are optional. If included, there should be convincing evidence of the applicant institution’s commitment to CASEL. For a CASEL with involvement of multiple geographic sites, all institutions involved may wish to provide documentation of their commitment to the CASEL.

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:

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 Inclusion Enrollment Report (Center Named Core)

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) 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.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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 New Investigators, or 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 the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

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

As applicable for the 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.

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?

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?

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?

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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

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

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

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

Not Applicable

Not Applicable

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 grantee’s business official.

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

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

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.

Awardee-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 awardee institution will provide the TRSP, NIH with written plans for project 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

Cooperative Agreement Terms and Conditions of Award

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, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees 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 awardees and participating NIH and FDA staff to facilitate scientific collaboration, data sharing and reporting/dissemination;
• 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; and

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 voting 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 awardees;
• 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 voting member of the CASEL Steering Committee;
• Providing technical assistance and scientific input to CASEL;
• Helping to coordinate collaborative efforts that involve multiple awardees;
• 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, non-voting 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;
• 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 awardee. This special dispute resolution procedure does not alter the awardee'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.

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Mary Kautz, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: [email protected]

Samuel Edwards, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1246
Email: [email protected]

Amy Bucheimer
National Institute of 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 and 45 CFR Part 75. 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.