EXPIRED
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.
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).
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:
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:
Rapid surveillance of tobacco product marketing:
Rapid surveillance of tobacco product marketplace:
The following types of studies are considered non-responsive to this RFA:
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:
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:
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:
7) Provide operational, administrative, and logistical support for the CRST, including:
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:
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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
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
For-Profit Organizations
Governments
Other
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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.
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.
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:
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: [email protected]
All page limitations 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 an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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).
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (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.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 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.
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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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).
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 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have 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?
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 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.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable.
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 (GDS).
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), 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:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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:
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:
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:
Designated NIH Tobacco Regulatory Science Program (TRSP) scientific staff, acting as a Project Coordinator, will have the following responsibilities reflecting substantial scientific-programmatic involvement:
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:
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.
Composition. The CRST Steering Committee will consist of the following members:
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.
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.
We encourage inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://grants.nih.gov/support/index.html
(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)
Email: [email protected] (preferred
method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov
registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Maria Roditis, PhD, MPH
National Cancer Institute (NCI)
Telephone: (240) 276-5326
Email: [email protected]
Center for Scientific Review (CSR)
Email: [email protected]
Crystal Wolfrey
National Cancer Institute
Telephone: 240-276-6277
Email: crystal.[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 and 2 CFR Part 200.