Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.  The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives,

Office of Disease Prevention (ODP)

Funding Opportunity Title

Center for Rapid Surveillance of Tobacco (CRST) to Assess Changes in Use Behaviors, Product Marketing, and the Marketplace (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-OD-22-002

Companion Funding Opportunity

NOT-OD-22-011 - U54 Specialized Center- Cooperative Agreements,  Notice of Intent to Publish a Funding Opportunity Announcement for the Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54 Clinical Trial Not Allowed)

NOT-OD-22-017 - U54 Specialized Center- Cooperative Agreements, Notice of Intent to Publish a Funding Opportunity Announcement for Tobacco Centers of Regulatory Science for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trials Optional)

Assistance Listing Number(s)

93.077

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications for a Center for Rapid Surveillance of Tobacco (CRST) to assess changes in use behaviors, product marketing, and the marketplace to better understand the rapidly evolving tobacco landscape in the United States. The CRST will support time-sensitive data acquisition strategies, data harmonization, data synthesis and analysis, and reporting activities on emerging and current tobacco use. Applications should focus on rapid surveillance, timely signals, and rapid reporting of information on changes in tobacco product use behaviors, tobacco product marketing, and the tobacco product marketplace. 

The award under this FOA will be administered by NIH using funds that have been made available through the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. Research must address the research priorities related to the FDA CTP regulatory authority.

Key Dates
Posted Date

December 16, 2021

Open Date (Earliest Submission Date)

April 18, 2022

Letter of Intent Due Date(s)

March 20, 2022

Application Due Date(s)

May 18, 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s)

No late applications will be accepted for this Funding Opportunity Announcement.

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

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

November 2022

Advisory Council Review

January 2023

Earliest Start Date

April 2023

Expiration Date

May 19, 2022

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

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


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Pre-Application Webinar

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

    Purpose

    This Funding Opportunity Announcement (FOA) seeks applications for a Center for Rapid Surveillance of Tobacco (CRST) to assess changes in use behaviors, product marketing, and the marketplace to better understand the rapidly evolving tobacco landscape in the United States.  The CRST will support time-sensitive data acquisition strategies, data harmonization, data synthesis and analysis, and reporting activities on emerging and current tobacco use trends. Applications should focus on rapid surveillance, timely signals, and rapid reporting of information on changes in tobacco product use behaviors, tobacco product marketing, and the tobacco product marketplace.

    The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from the CRST are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

    Background

    The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by the President in June 2009, created the FDA CTP and granted it authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health.  A full description of the FSPTCA can be found at:

    https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview .

    The tobacco product landscape and use behaviors have been rapidly evolving in recent years. Significantly, there was a rapid increase in the use of electronic nicotine delivery systems (ENDS) by youth observed in the 2018 and 2019 National Youth Tobacco Survey (NYTS) and a surge in disposable ENDS use in 2020. Moreover, the shift in age of initiation of smoking from youth into young adulthood, and persistent tobacco-related disparities (including but not limited to racial/ethnic minorities, people with mental health comorbidities, and the LGBTQ population), underscore the FDA’s need to understand, document, and quantify changes in the tobacco product marketplace and tobacco use patterns among different segments of the population to inform tobacco product regulatory activities.  Rapid or sentinel data sources or systems can provide timely data on changing tobacco use patterns; information about conventional and newly authorized products and the factors that contribute to their use; and observe changes in the tobacco marketplace. Given the variability in policy contexts, the evolving nature of the tobacco product marketplace, and industry marketing practices, it is important for the FDA to have access to ongoing, time-sensitive surveillance information to assess tobacco product use patterns, factors that contribute to tobacco product use, and changes in the tobacco marketplace.

    Research Objectives

    This Funding Opportunity Announcement (FOA) seeks applications for a single Center for Rapid Surveillance of Tobacco (CRST) to better understand the rapidly evolving tobacco landscape in the United States. The goal is to complement existing surveillance systems by providing data and information to the FDA CTP and federal partners on a more frequent basis and shorter timeline than typical surveillance methods. Areas of interest include the rapid surveillance of changing tobacco use patterns among tobacco product user groups and the factors that contribute to these changing patterns; rapid surveillance of tobacco product marketing; and the rapid surveillance of changes in the tobacco marketplace, including emerging products and tobacco products that are modified by the user.

    Applicants are encouraged to submit strategies for time-sensitive data collection, data harmonization, data synthesis and analysis, and reporting. Applications may take advantage of existing cohorts, panels, social media data, retail sales data, observational studies, environmental scanning, focus groups, or ecological momentary assessments that can provide timely and/or “boots on the ground” information on a more frequent basis than traditional research or reporting. In addition, partnerships may be formed with community or public health partners (e.g., tobacco control organizations, school and education systems, local departments of health, health care providers, public mental health/substance abuse or health care systems, child welfare agencies) who monitor or address challenges with tobacco products and their use. Data should be geographically diverse and account for relevant subpopulations, and when available and appropriate, nationally representative. The CRST will maximize data sources that can serve as a signal detection system for findings that traditional data sources can help validate. Moreover, rapid or sentinel data sources are more able to adapt data collection methods or instruments to capture the current tobacco landscape. 

    The CRST will work collaboratively with NIH and FDA CTP to implement a model that utilizes multiple data sources to identify emerging tobacco use issues, and to track tobacco use trends through regular monitoring of key data from sentinel sites. Varying approaches to collecting data, such as web-based surveys, data mining (e.g., social media or marketing data), crowdsourcing, and development of strategies for the timely and effective reporting of findings should serve as central functions performed by the CRST. The network of sentinel sites may consist of community experts and data from other sources, to complement the core functions of the CRST.

    Data from the CRST will have a substantial public health impact and will inform the regulation of tobacco products by providing timely and potentially actionable information about changes in tobacco product use patterns, tobacco products and the factors that contribute to their use, and changes in the tobacco marketplace before more traditional data collection mechanisms have information available.

    This RFA seeks innovation and direction from the scientific community in devising and implementing an optimal rapid surveillance program -- including approaches to data collection, forming collaborative networks, data harmonization, analysis, and reporting -- while maintaining NIH and FDA scientific input to assure consistency with FDA CTP priorities and regulatory authorities.

    Investigators are strongly encouraged to discuss whether their application is responsive to 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/.

    Topic Areas 

    The CRST must address the following:

    Rapid surveillance of changes in tobacco product use behaviors:

    • Changes in tobacco use behaviors (e.g., type of tobacco product, quantity, frequency) among youth, young adults, and other populations with tobacco-related disparities such as racial/ethnic minorities, those with lower socioeconomic status, people with mental health comorbidities, and sexual or gender minorities,  underserved rural populations,  those pregnant or trying to become pregnant, and those in the military or veterans , and factors that contribute to their use behaviors, e.g., access, labeled product characteristics (e.g., brand, packaging, nicotine concentration, flavors, components, design features), price promotions, advertising, social media marketing, social media discussions
    • Changes in how youth, young adults, and populations with tobacco-related disparities access or obtain tobacco products
    • Emerging use behaviors such as:
    • ·    Users adjusting the components, ingredients, or features of their products (including devices and/or contents) and the result of those modifications
    • ·    Users producing their own flavored tobacco products (including mixing their own flavors into ENDS liquids or refilling e-liquid cartridges with their own mixtures).

    Rapid surveillance of tobacco product marketing:

    • Describe recent changes in the mechanisms or platforms of current tobacco product marketing in traditional and non-traditional communication channels, including owned or earned media, social media influencers, brand ambassadors, outreach events, or other digital marketing of tobacco products.
    • Describe recent changes in industry tobacco product marketing strategies, including retailer (online or brick and mortar), promotional practices, such as point-of-sale marketing, price promotions, coupons, and/or affiliate marketing. Is there evidence that these marketing strategies have disparate effects on populations with tobacco-related disparities?

    Rapid surveillance of tobacco product marketplace:

    • Describe recent changes in the tobacco retail environment for existing and/or emerging tobacco products including traditional stores such as grocery, convenient, and “big-box” stores, and gas stations; as well as tobacco specialty shops such as vape shops, “head” shops, cigar bars and hookah bars.
    • Describe recent changes and/or trends in tobacco product sales in tobacco specialty shops (e.g., vape shops, cigar bars, hookah bars), as well as online retailers, for deemed tobacco products (e.g., ENDS, cigars, hookah/waterpipe) and products that have recently obtained a marketing authorization.

    The following types of studies are considered non-responsive to this RFA:

    • Human laboratory studies, e.g., topography, fMRI
    • Laboratory analysis of tobacco products, e.g., smoking machine, device analysis
    • Biospecimen collection or analysis
    • Environmental scan of policies

    Responsibilities of the (CRST):

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

    1) Establish and convene meetings of a CRST Steering Committee that shall advise in the conduct of the project; identify priority variables and populations for surveillance; provide guidance on establishing procedures for harmonizing data from different sources and communities; provide guidance on procedures for presentation, interpretation and analysis of data within and across sentinel sites; provide guidance in establishing methods for assessing trends over time; identify opportunities and methods for collecting data to enhance understanding of emerging tobacco use trends; and identify findings that are priorities for reporting to the scientific community and other stakeholders, (e.g., local health departments, tobacco control programs, health providers).  

    2) Establish one or more CRST-led surveillance and/or data analysis initiatives to serve as a core set of indicators with a priority on regular surveillance of youth, young adults, and other populations with tobacco-related disparities on emerging tobacco use patterns and factors that contribute to their use. Key components may include:

    • Analysis of survey panels and cohorts
    • Analysis of data from the internet and social media
    • Analysis of sales and marketing data
    • Exploration of open-source analytic tools, e.g., Google Trends, or other programs that assess trends
    • Utilizing various approaches to collect data, such as web-based surveys, data mining and use of crowdsourcing

    A program goal is improving the yield and impact of the tobacco regulatory science portfolio through enhanced capacity for sharing and comparing data, replicating findings, and integration of data from multiple sources. As such, use of common study variables, criteria, and protocols, where appropriate, is strongly encouraged. After awards are made, investigators will be expected to collaborate with other recipients, the NIH-FDA designated coordinating center (Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) for Tobacco Regulatory Science), and NIH and FDA CTP scientific staff on the development and use of shared and standardized measures, methods, and data management wherever feasible to facilitate data aggregation and collaborative activities across projects. As such, investigators are expected to incorporate PhenX measures, other common data elements, and/or measures recommended by Tobacco Regulatory Science (TRS) working groups as appropriate.

    3) Develop and maintain a sentinel site network composed of experts on tobacco control data from selected priority communities to assist in the ongoing monitoring and interpretation of data. Sentinel sites may include CTP-funded research projects, ongoing surveys, and other surveillance programs.  CRST will also coordinate with CTP as a sentinel site given that it has on-going efforts to collect and analyze tobacco products sales data, analyze poison control center data regarding unexpected tobacco health effects, and monitor social media sites. Collectively, the sentinel site network should include urban and rural areas, and populations and localities of relevance for particular tobacco product classes or risk factors, and populations with tobacco-related health disparities. Sentinel sites may change over the course of the project period depending on changing tobacco use trends. In consultation with the Steering Committee and the sentinel site network, CRST will establish key community-level indicators for monitoring to identify new tobacco product use and emerging tobacco use issues, including plans for use of common data elements, consensus measures, and/or harmonizing of indicators; presentation and analysis of indicators across the selected communities; and reporting of data and findings.

    4) Conduct cross-site data analyses from harmonized CRST data, including:

    • Establishing annual sentinel site profiles based on descriptive analyses of key indicators, including parameters for assessing changes over time using multiple data sources
    • Considering regional and socio-demographic factors, including gender, race/ethnicity, and other factors of tobacco-related disparities, in analyzing data
    • Working with the NIH-FDA designated coordinating center (CASEL) to facilitate cross-site analyses and collaborative projects with other CTP-funded investigators

    5) Reporting to NIH and FDA on a regular basis, i.e., every other week, and more often as needed via a password protected website. Virtual meetings or conference calls may also be scheduled to discuss findings on an as-needed basis.

    6) Identify approaches for translating, reporting, and publishing CRST findings for the scientific community and other stakeholders (e.g., local health departments, tobacco control programs, health providers). These approaches should be vetted through the CRST Steering Committee and should include:

    • Peer reviewed publications and presentations at research conferences including the NIH TRS grantee meetings
    • Conducting webinars of timely findings in coordination with CASEL
    • Project website to describe the surveillance program, activities, and report findings of note
    • Other activities, to be approved through the Steering Committee, that allow for the timely reporting of findings of note to the appropriate audiences.  (e.g., listservs, press releases, reports)

    7) Provide operational, administrative, and logistical support for the CRST, including:

    • Planning, organizing, and conducting meetings of the Steering Committee
    • Planning, organizing, and conducting periodic internet-facilitated virtual meetings of sentinel site collaborators. More frequent shorter conference calls may be established in response to emerging tobacco issues
    • Compiling meeting minutes, delivering summary meeting reports, and coordinating post-meeting follow-up
    • Providing technical or logistical support for meetings of subcommittees and workgroups including providing conference call lines and webinar support

    Governance of CRST

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

    CRST will be governed by a Steering Committee, to be established. The Steering Committee will advise the PD/PI and monitor the activities of CRST, including the policies, procedures, and strategies that pertain to its rapid surveillance activities. These activities include but are not limited to collaboration with sentinel sites and other research investigators, and participation in working groups and grantee meetings facilitated by the NIH-FDA designated coordinating center, the CASEL. The Steering Committee will have the ability to establish sub-committees to advise the larger Steering Committee. The CRST Steering Committee will work collaboratively across its membership, comprised of representatives from CRST (PD(s)/PI(s)), CASEL, CDC, NIH and the FDA CTP scientific staff, and external advisors with relevant expertise. The CRST Steering Committee will also work collaboratively with sentinel site investigators and any investigators with relevant ongoing surveillance or findings.

    Applicants should not identify or contact proposed outside experts. Rather, they should explain what areas of expertise should be represented by outside experts who will serve throughout the grant period or on an ad hoc basis (give examples, e.g., areas of expertise plus analysis/methods, dissemination). At minimum, Steering Committee meetings should be held three times a year, with two held virtually and one held in-person, if conditions allow, in the Rockville/Bethesda, Maryland area to coincide with annual TRS grantee meetings. 

    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 expect investigators involved in human-subjects studies to employ 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 available in the PhenX Toolkit (www.phenxtoolkit.org), including the Tobacco Regulatory Research Core and Specialty Collections. Please see NOT-OD-17-034 for further details.
    • Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance set forth by The National Advisory Council on Drug Abuse (NACDA) 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 FOA.
    • 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.

    NOTE: Applicant institutions may submit multiple applications in response to this FOA and the Notice of Intent to Publish NOITP (TCORS) and NOITP (CASEL).  The CRST PD/PI recipient, however, cannot serve as PD/PI of a TCORS recipient nor as key personnel of a CASEL recipient.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials.

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIH, via support from the FDA Center for Tobacco Products (CTP), intends to fund one award, corresponding to up to $2.8 million total costs for fiscal year 2023 and up to $3.8 million total costs per year for subsequent years. 

    Year 1 funding is capped at $2.8 million total cost to account for lead time needed for project start-up. Budget needs to reflect actual needs of the proposed project and future year funds after Year 1 will depend on availability of funds.

    Award Budget

    A U01 center may not exceed $2.8 million in total costs in Year 1 or $3.8 million in total costs per year in subsequent years.  

    Award Project Period

    The maximum project period is 5 years. 

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

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

    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.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

     

    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    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 asked 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: 301-480-5588
    Email: TRSP@nih.gov

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

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

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:  The research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  If the research data are cited publicly in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in 2 CFR 200 (http://gpo.gov/fdsys/pkg/CFR-2015-title2-vol1/pdf/CFR-2015-title2-vol1-part200.pdf ) and the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch2.htm#info_confidentiality).

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. CRST must provide NIH and FDA CTP with access to all the data generated under this award, subject to rules specified in any Certificate of Confidentiality obtained by the recipient.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form

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

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

    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

    4. Submission Dates and Times

    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). 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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    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.  

    7. Other Submission Requirements and Information

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

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this FOA for information on registration requirements.

    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. 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive to the scientific interest areas identified in this FOA, and/or proposing work outside FDA-CTP's regulatory authority will not be reviewed.

    In order to expedite review, applicants are requested to notify the Tobacco Regulatory Science Program by email at TRSP@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

     

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

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

    Scored Review Criteria

    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.

    Significance

    Does the project address an important issue or a critical barrier in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

    Investigator(s)

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

    Innovation

    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?

    Approach

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

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

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

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

    Environment

    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?    

    Additional Review Criteria

    As applicable for the project 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.

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

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

    Vertebrate Animals

    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.

    Biohazards

    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.

    Resubmissions

    Not Applicable.

    Renewals

    Not Applicable.

    Revisions

    Not Applicable.

    Additional Review Considerations

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

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

    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).

    Resource Sharing Plans

    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 (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 Cancer Advisory Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    • Additional institutional support.
    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

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

    2. Administrative and National Policy Requirements

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

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

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

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

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

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee  Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

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

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

    The PD/PI of the CRST will have the following responsibilities:

    • Defining objectives and approaches, and planning and directing the surveillance activities of the CRST with regard to the CTP-funded research portfolio in accordance with the goals of this initiative;
    • Ensuring and overseeing timely results reporting, including preparation and publication of scientifically rigorous manuscripts and dissemination of relevant findings by other appropriate means;
    • Serving as members of the CRST Steering Committee and participating in relevant subcommittees;
    • Attending the annual TRS Investigator Meetings;
    • Accepting and implementing priorities, procedures, and policies agreed upon by the CRST Steering Committee to the extent consistent with applicable grant regulations;
    • Overseeing the implementation for their respective surveillance projects of the common processes and procedures approved by the CRST Steering Committee;
    • Informing the NIH Program Official of plans to change or modify any project’s specific aims or research strategy, and obtaining receipt of NIH and FDA approvals prior to the implementation of changes and expenditure of funds;
    • Cooperating with the CASEL and TCORS, and other TRS-funded investigators, and with Federal staff members in various joint activities; examples include: research collaborations and working groups;
    • Coordinating, as needed, activities associated with individual research projects with those of CASEL; and
    • Cooperating with the Federal staff members and/or external evaluators in the course of an evaluation process;
    • Ensuring the conducted research remains within the scope of the regulatory authority of the FDA CTP;
    • Informing the NIH Program Official of plans to change or modify any project’s specific aims or research strategy, and obtaining receipt of NIH and FDA approvals prior to the implementation of changes and expenditure of funds;
    • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

    Designated NCI scientific staff, acting as the Project Collaborator, will have the following responsibilities reflecting substantial scientific-programmatic involvement:

    • Reviewing the progress of the recipient;
    • Serve as a resource for specific information on NCI's programmatic intentions and priorities, and help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants;
    • Providing advice and technical assistance regarding the conduct of research;
    • Play an active role in developing innovative methodological strategies to support data harmonization (e.g., data quality control, assessing and resolving cross site variation) comparability);
    • Identify relevant research questions.  He/she may cooperate with recipients in development, design, and coordination of surveillance plans and reports; and

    In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIH and FDA may cooperate with recipients as coauthor in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH and/or FDA staff require internal clearances.

    In addition, a designated NCI program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI Program Official, who will not participate in the research or the preparation of publications, will be responsible for the oversight of the cooperative agreement. The Program Official carries primary responsibility for:

    • Periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the CRST staff as well as requests for additional reports or documentation;
    • Making recommendations regarding continuance of the program. The NCI Program Official will be responsible for monitoring the conduct of the project and overseeing the CRST. The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NCI Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement.

    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 member of the CRST Steering Committee;
    • Providing technical assistance, advice, and coordination of efforts to recipient;
    • Helping to coordinate collaborative efforts that involve multiple recipients;
    • Identifying and providing relevant content expertise on behalf of NIH and FDA, and serving in a liaison role;
    • Cooperating with the recipient to support the research and dissemination of findings of the individual projects;
    • Assisting the CRST Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action;
    • Monitoring CRST and associated sentinel site grantee activities for responsiveness to FDA CTP regulatory authorities; and
    • Reviewing (together with NIH and FDA partners) the progress of each participating institution

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

    • Serving as members of the CRST Steering Committee;
    • Providing technical assistance, scientific input and coordination of efforts to CRST;
    • Identifying and providing relevant content expertise to the individual research projects, as needed;
    • Cooperating with the PDs/PIs to support the research and dissemination of findings of the individual projects;
    • Assisting the CRST Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action; and
    • Reviewing (together with NIH program officials) the progress of each participating institution and compliance with the components to collaborative efforts.  

    Additional NIH and FDA staff may participate in all project related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

    The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.

    The Government, via the NIH and FDA Project Coordinators, Project Collaborators and Program Officials, will have access to data generated under this Cooperative Agreement through grantee meetings and progress reports. Federal staff may use information obtained from the data for the preparation of internal reports on the activities of the study.  

    Areas of Joint Responsibility include:

    CRST Steering Committee

    Roles. The CRST Steering Committee will be the main governing body for this initiative and will provide input on scientific matters. The CRST Steering Committee members will provide scientific and technical input into discussions of pooled and collaborative research projects where relevant.

    The CRST Steering Committee, in partnership with NIH and FDA members, will monitor the progress of these projects, facilitate common data sharing and group publications and identify common resources to support such efforts.

    • Recipient, NCI Project Collaborator, and TRSP and FDA Project Coordinators (federal partners) will jointly propose and select members of the Steering Committee. The Recipient and federal partners will jointly plan agendas for meetings.
    • The dissemination plan will be jointly developed and mutually acceptable to both the recipient and federal partners.
    • Status reports in the format of conference calls with federal partners will take place on a monthly basis, or more frequently, as needed. These reports will include information concerning project progress, obstacles and steps taken to remedy them. Status reports will also discuss the results of studies as they become available.

    Composition. The CRST Steering Committee will consist of the following members:

    • CRST PI(s);
    • NCI Representative;
    • TRSP Representative;
    • FDA Research Representative;
    • FDA Surveillance Representative
    • CASEL Representative;
    • CDC Representative;
    • Three external advisors with expertise relevant to the listed Topic Areas, and additional advisors if needed.

    NIH and FDA reserve the right to augment the scientific expertise of the CRST Steering Committee as it deems necessary.

    All Recipients will be required to accept and implement policies approved by the CRST Steering Committee to the extent of corresponding grant regulations.

    NIH staff will maintain authority on all matters regarding funding or expenditure of funds.

    Subcommittees. The CRST Steering Committee may establish subcommittees or workgroups to provide input on specific matters as needed. The NIH and FDA Project Scientists/Coordinators will serve on subcommittees or task forces, as they deem appropriate. Subcommittees or task forces may also include other representatives from NIH or FDA. The CRST Steering Committee may invite additional scientific advisors to the meetings.

    Meetings. The CRST Steering Committee will meet, at minimum, three times a year, in consultation with NIH and FDA. Two meetings will be held virtually and one will be held in-person, if conditions allow, in the Rockville/Bethesda, Maryland area in conjunction with the annual TRS grantee meetings. In addition, the CRST Steering Committee will meet regularly by conference call. The PD/PI and senior investigators from each core component and/or sentinel site must participate in all conference calls as appropriate. The CRST Steering Committee may invite additional individuals to participate as appropriate.

    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 three members will be convened. It will have three members: a designee of the CRST Steering Committee, chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

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

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

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

    Finding Help Online: https://grants.nih.gov/support/index.html (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Maria Roditis, PhD, MPH
    National Cancer Institute (NCI)
    Telephone: (240) 276-5326
    Email: maria.roditis@nih.gov

    Peer Review Contact(s)

    Center for Scientific Review (CSR)
    Email: FOAReviewContact@CSR.NIH.gov

    Financial/Grants Management Contact(s)

    Crystal Wolfrey
    National Cancer Institute
    Telephone: 240-276-6277
    Email: crystal.wolfrey@nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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