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

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Smoking Cessation within the Context of Lung Cancer Screening (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-15-011

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.396, 93.399, 93.393   

Funding Opportunity Purpose

The goal of this Funding Opportunity Announcement (FOA) is to improve the effectiveness and/or implementation of smoking cessation interventions delivered to current smokers who undergo low-dose computed tomography (LDCT) lung cancer screening. The proposed projects must be aimed at determining:

a) the key components and characteristics of an effective smoking cessation intervention delivered in the LDCT setting; and/or

b) characteristics of an implementation strategy to optimally incorporate existing evidence-based smoking cessation intervention(s) into the LDCT setting.

The projects must include prospective, comparative evaluation of the intervention(s) in terms of the rates of cessation and sustained abstinence (6-12 months after cessation) among current smokers undergoing screening. The LDCT screening site must be the essential context for the delivery of the cessation intervention, although interventions may also include services provided outside the site before or after screening.

Key Dates
Posted Date

June 5, 2015

Open Date (Earliest Submission Date)

September 8, 2015

Letter of Intent Due Date(s)

September 8, 2015

Application Due Date(s)

October 8, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

March-April 2016

Advisory Council Review

May 2016

Earliest Start Date

July 2016

Expiration Date

October 9, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.

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

The goal of this Funding Opportunity Announcement (FOA) is to support the development and testing and/or implementation of smoking cessation interventions delivered to current smokers who undergo low-dose computed tomography (LDCT) lung cancer screening. The proposed projects must be specifically focused on the LDCT setting and must be aimed at determining:

  • the key components and characteristics of an effective smoking cessation intervention; and/or
  • the characteristics of an implementation strategy to optimally incorporate existing evidence-based smoking cessation interventions.   
Background

Smoking causes many types of cancer, including those of the lung, esophagus, larynx, mouth, throat, kidney, bladder, pancreas, stomach, and cervix, as well as acute myeloid leukemia. The U.S. Surgeon General reported in 2014 that smoking and exposure to tobacco smoke cause more than 480,000 premature deaths from cancer, heart disease, stroke, lung disease, and other outcomes in the United States each year. These numbers include 41,000 deaths resulting from secondhand smoke exposure. In addition, some subpopulations (e.g., subpopulations sharing a particular race, ethnicity, or socioeconomic status) suffer disparately elevated risks related to smoking. Quitting smoking reduces these health risks in both the general population and more vulnerable subpopulations.

Lung cancer remains the leading cause of cancer death among both men and women in the United States and many other high-income countries. The American Cancer Society (ACS) estimates that 158,040 Americans will die from lung cancer in 2015. Although some recent reductions in lung cancer deaths have been observed as a result of primary prevention—specifically, as a result of the decline in smoking rates noted over the last 50 years—death rates among those diagnosed with lung cancer have remained at a high level.

Lung cancer screening evidence and recommendations. From 2002 to 2006, the National Cancer Institute (NCI)-funded National Lung Screening Trial (NLST) randomly assigned more than 50,000 asymptomatic individuals ages 55 to 74 who were current or former heavy smokers to receive periodic screening via LDCT or chest x-ray. Heavy smokers were defined as those with at least a 30 pack-year history of smoking (where "pack-year" is the product of the number of packs smoked per day multiplied by the number of years as a smoker). Trial results indicated that LDCT screening was associated with a reduction in lung cancer mortality of about 20%. Subsequently, the U.S. Preventive Services Task Force (USPSTF) has concluded that LDCT screening can significantly reduce mortality from lung cancer among heavy current and former smokers. Based on this finding, the USPSTF recommended that asymptomatic adults age[s] 55 to 80 who have a 30 pack-year smoking history and currently smoke or have quit smoking within the last 15 years should be screened annually for lung cancer with LDCT, and that screening should continue until the patient has not smoked for 15 years. This was a grade B recommendation, signifying that there is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial. Many clinical and organizations (e.g., American College of Chest Physicians, ACS, American Society of Clinical Oncology, American Thoracic Society, American College of Radiology) also have endorsed annual LDCT screening for current and former heavy smokers.  The Centers for Medicare and Medicaid Services (CMS) determined that Medicare will cover LDCT for individuals ages 55-77 with a 30 pack-year smoking history, who are either current smokers or have quit within 15 years. The release of lung cancer screening recommendations has led to a marked increase in the number of radiology sites that provide LDCT scans for lung cancer screening. Availability is expected to increase further given the Affordable Care Act’s requirement that all grade A or B USPSTF prevention recommendations be covered as part of the basic benefit package of all insurers.

Rationale for smoking cessation in conjunction with lung cancer screening. The U.S. Public Health Service (PHS)-sponsored Treating Tobacco Use Guideline (“PHS Guideline”) states that “[I]t is essential that clinicians and health care delivery systems consistently treat every tobacco user seen in a health care setting.” Providing smoking cessation treatment in conjunction with annual lung cancer screenings appears to be a highly cost-effective way to reduce smoking-related morbidity and mortality. Nevertheless, smoking cessation is not a universal component of screening programs.

There is support from professional organizations and insurers for LDCT sites to provide cessation treatment. Medicare coverage will require that patients receive a written order for lung cancer screening from a clinician after a shared decision-making visit. In addition to the discussion of screening, that visit must include brief cessation counseling and furnishing of information about tobacco cessation services. Medicare coverage also requires that smoking cessation interventions are made available by the radiology imaging facility. Smoking cessation treatment delivered with LDCT screening offers great potential to reduce tobacco use rates and smoking-related morbidity and mortality in the large population of smokers. An estimated 8.6 million Americans were eligible for LDCT screening as of 2010. In lung cancer screening studies that included current and former smokers, approximately 50% of lung cancer screening participants were current smokers. Meta-analyses reported in the PHS Guideline indicate that cessation medication combined with eight sessions of counseling is associated with long-term (6 months or more) abstinence rates of approximately 33%. Cessation attempted without counseling or medication yielded abstinence rates of 10–11%.

LDCT lung cancer screening also appears to provide an opportunity to deliver evidence-based smoking cessation treatments to individuals who may be particularly receptive to a cessation intervention. Seeking out and receiving lung cancer screening is associated with high risk perception. Lung cancer screening studies have found an increased motivation to quit smoking and higher rates of cessation among screening trial participants compared to spontaneous cessation in the general population, and a statistically significant increase in smoking cessation among individuals with an abnormal LDCT scan compared to those without abnormal results. Conversely, the prospect of wide implementation of LDCT screening has also raised concerns that motivation to quit might be decreased for some individuals (if screening decreases their perceived risk of lung cancer, for example). An absence of smoking cessation assistance in the LDCT setting might also indicate to patients that cessation is not an essential component of the healthcare service. Appropriately designed cessation interventions can increase and leverage patients' motivation to quit smoking.

The need for cessation research in the LDCT setting. Because LDCT screenings provide a new environment, previous research on smoking cessation cannot be applied without consideration of the setting. Additionally, clinical pathways are varied: patients presenting for LDCT may have been referred by a clinician or self-referred; follow-up after the scan might include further contact with the LDCT clinic, a primary care physician, or other health professionals. Radiology clinics have not traditionally provided cessation counseling. The clinics typically have high patient volume. Little research exists on the format, components, dose, and timing for cessation treatment that will be feasible in conjunction with an LDCT scan.

Research Objectives

This FOA is designed to stimulate research on optimal cigarette smoking cessation approaches delivered in conjunction with LDCT lung cancer screening visits in a variety of LDCT screening settings.

Research responsive tor this FOA is limited to well-developed intervention-based projects focused on one the two areas described below or their combination:   

(Area 1) Design of new smoking cessation interventions or substantial modifications of evidence-based interventions to be delivered in conjunction with LDCT visits. Such projects may compare different counseling components and pharmacotherapy approaches. Research may examine the timing of the intervention (e.g., number and schedule of treatment contacts, when they are delivered relative to the actual screening test), phases of smoking treatment (e.g., interventions to motivate smokers to quit, prepare them for quitting, support cessation, prevent relapse), and treatment intensity (e.g., the number and/or duration of interventions offered). Research questions may include the following: How can cessation interventions best take advantage of shared decision-making and counseling visits that precede LDCT screening covered by Medicare? How should screening results be integrated with or inform the smoking cessation intervention? Are there risk communication/physiologic feedback approaches that maximize the rates of successful smoking cessation and minimize possible adverse effects of screening on cessation motivation? Studies that incorporate state-of-the-science health communication theory and knowledge are encouraged.

 (Area 2) Implementation: testing approaches for implementing existing effective interventions in the LDCT setting. Projects of this type may address the following questions: What are the barriers and what implementation strategies are effective in increasing the uptake of smoking cessation interventions within LDCT sites?  What training and supervision models of clinical and front-line staff lead to higher quality delivery of these interventions? Are there specific clinic-level strategies that lead to higher sustainability of interventions over time?  Do improved information systems or decision support applications promote the use of smoking cessation interventions that are appropriate for the patients’ preferences?  What resources would be needed to scale up the intervention to other LDCT screening settings? What systemic approaches improve scale-up of cessation interventions across LDCT sites within large health care systems or networks?

(Combination of Areas1 and 2) Hybrid efficacy-implementation trials. Some studies may seek to test both novel cessation interventions and implementation strategies jointly under one project.  These hybrid trials may combine, as appropriate, key questions from both sections above.

All projects must include traditional randomized clinical trials, pragmatic trials, or other comparative designs. Additional requirements are listed below.

  • Projects must include rigorous testing to identify the key characteristics that are essential for the cessation interventions to be clinically effective.
  • The following endpoints/characteristics are required for all studies: rates of cessation and sustained abstinence (6-12 months), cessation intervention fidelity, patient acceptance and engagement, patient reach (i.e., the absolute number, proportion, and representativeness of individuals who are willing to participate), cost, and the ease of delivery and feasibility (e.g., effects on clinic workflow).
  • The LDCT screening site must be an essential site for the delivery of the cessation intervention, although interventions may also include services provided outside the site before or after screening.

Research projects proposed under this FOA may, in addition, address one or more of the following key knowledge gaps:

  • How do interventions compare with respect to provider reach (i.e., the absolute number, proportion, and representativeness of LDCT sites that are willing to participate) and cost-effectiveness?
  • How do cessation rates differ based on the LDCT results?  That is, does an unremarkable scan lead to perceptions of decreased health risk, and is this, in turn, associated with reduced quitting motivation and higher rates of continued smoking? If LDCT indicates possible cancer, how are perceptions of risk associated with smoking and cessation motivation affected?
  • Does the efficacy of cessation support received at LDCT lung cancer screening sites, reaction to screening feedback, or response to the cessation treatment vary by smoker characteristics? What are the implications for cessation of the characteristics of smokers who seek LDCT? Do members of vulnerable populations (e.g., patients who experience health disparities related to low socioeconomic status, mental health or other co-morbidities, or race or ethnicity) respond differently to cessation services provided with screening?

Annual meeting: Awardees under this FOA will be expected to participate in an annual investigators’ meeting that may be hosted on a rotating basis at the participating PD/PIs' institutions.  The meetings will provide a venue for presenting scientific findings from each of the funded studies and will facilitate interactions among the growing community of scientists. PDs/PIs will be expected to participate in conference calls for planning purposes biannually or at other appropriate intervals. The investigators may form committees that meet periodically by conference calls as needed.

Standardization and coordination: Funded investigators should, to the extent possible, collaborate and report in a standardized manner when they are measuring key common variables. Investigators may also collaborate in the development of formative tools, approaches to dissemination, and other areas of shared investigator interest.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCI intends to commit $4,500,000 in FY2016 to fund up to 6 awards.

Award Budget

Application budgets are limited to $500,000 in direct costs in any one year. Because the nature and scope of the proposed research will vary from application to application, budget requests need to reflect the actual needs of the proposed project. It is anticipated that the maximal allowable budget will be requested only in case of particularly comprehensive approaches, e.g., projects testing several interventions.

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 in response to 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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

  • 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 not 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.  This means that the NIH will not accept:

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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

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:

Stephanie R. Land, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6946
Fax: 240-276-7907
Email: landsr@mail.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. The following additional instructions apply.

The LDCT screening site must be an essential site for the delivery of the cessation intervention, although interventions may also include services provided outside the site before or after screening.

SF424(R&R) Other Project Information

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

Facilities and Other Resources: In addition to standard items, list/document the characteristics of the LDCT clinical settings in which the proposed interventions will be conducted. Include relevant documentation showing the facility readiness for conducting the smoking cessation intervention trials.  This documentation should cover the characteristics of the LDCT settings that are relevant to the proposed interventions, including characteristics of the available patient population, geographic setting, resources, space, personnel, knowledge, business model, etc.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  The following additional guidance applies.

If appropriate and desirable, applicants may include as Senior/Key persons  individuals who are affiliated with the LDCT clinic(s) in which the cessation interventions will be delivered (but this is not required).

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional guidance applies.

The budget request may reflect the costs attributable to the development, evaluation, and dissemination of cessation intervention(s) in the setting of LDCT screening, excluding any regular medical care costs that would be covered by insurance companies. Activities to be supported may include coordination, training, delivery, implementation; participant screening, recruitment, and engagement; and the development and dissemination of research products for adoption by other clinics. The request must NOT reflect the costs of the LDCT imaging or any other costs associated with routine patient screening and care.

Grantees will be expected to attend annual grantee meetings. It is recommended that the budget include funding for 2-3 investigators to travel to these annual grantee meetings.

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: 

Research Strategy: The entire Research Strategy must adhere to the general requirements listed in Section I of this FOA. The subsections indicated below should address the following specific aspects.

Significance:

  • Explain how the successful completion of the proposed research will facilitate the rapid development and implementation of effective cessation services in LDCT lung cancer screening centers.
  • Discuss the feasibility of scaling up the strategies to be developed and steps that might be needed to ensure that approaches will be suitable for the larger community of lung cancer screening clinics.

Preliminary Data:

  • Provide preliminary data regarding the efficacy of the smoking cessation interventions to be developed and other relevant documentation in support of the proposed project.

Approach:

The description in this sub-section must address and provide the necessary supporting details explaining how the proposed project will meet the following key requirements:

  • The design of clinical trials: All projects must include a traditional randomized clinical trial, pragmatic trial, or other comparative interventional research study. Observational studies may be proposed only as additional approaches.
  • Cessation endpoints: The interventions must be rigorously evaluated in terms of the rates of cessation and sustained abstinence (6-12 months after cessation) among current smokers undergoing screening.  Biochemical verification of abstinence is encouraged.
  • Implementation endpoints: All projects must assess cessation intervention fidelity, patient acceptance and engagement, patient reach (i.e., the absolute number, proportion, and representativeness of individuals who are willing to participate), cost, and the ease of delivery and feasibility (e.g., effects on clinic workflow). Projects in the second general research area (implementation of existing interventions) will be expected to provide a more rigorous evaluation of these implementation-oriented endpoints than projects that are developing new interventions.
  • Examples of other considerations applicable to all project types: Whether developing a novel cessation intervention or testing approaches to implementing evidence-based interventions, applicants should consider a variety of options with regard to the people and resources engaged in delivering the cessation intervention. These options may include the involvement of primary care physicians or others who provide referral to LDCT screening, LDCT clinical staff, community cessation services, telephone quitlines or Web-based cessation resources, and lung cancer screening registries. Related research questions include the following: To what extent is it vital that the LDCT lung cancer screening staff remain associated with cessation treatment versus providing a referral to an outside entity for treatment? Is engaging the primary care physician or other clinician who provided a written order for the LDCT important (providing continuity of care and reinforcing cessation)? Can follow-up visits (e.g., at one year for patients with an unremarkable scan) be leveraged to support cessation?

Investigators are strongly encouraged to use standard data collection measures to the extent possible given the scientific areas covered in the project. The Institute of Medicine reports entitled “Capturing Social and Behavioral Domains in Electronic Health Records” and other consensus documents and resources should be reviewed for relevant measures. Standard measures should be sought not only for human subjects domains, but also for measures that describe the LDCT setting (e.g., clinic organizational factors that will affect implementation: space, personnel, knowledge, and business plan). Applicants must also anticipate that funded investigators will be encouraged to use measures that are common across the funded projects, to the extent feasible and reasonable given the scientific areas covered in the projects.

The proposed smoking cessation and implementation strategies must be potentially feasible to scale up to other clinics upon the completion of the funded research, given realistic resources. Therefore, outline a realistic plan to sustain effective dissemination approaches once the research-funding period has ended. 

Investigators are also encouraged to indicate any relevant (ongoing or anticipated) interactions with other research initiatives, clinical trial groups, and clinical practice groups, as applicable, which remain beyond the scope of the project but may benefit the proposed research project and/or facilitate the dissemination of its results.

Letters of Support: In addition to standard items, include letter(s) of support documenting that the LDCT screening site will provide access to the research team for the delivery of smoking cessation interventions as needed and proposed.

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

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

Data Sharing Plans should describe the sharing of materials and tools (e.g. training protocols, data collection tools, technical assistance resources) at a level of detail that permit other LDCT clinics to implement the tested cessation intervention(s).

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. 

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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

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 problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA: Will this project, if successful, facilitate the rapid development and implementation of effective cessation services in LDCT lung cancer screening centers? Are the proposed smoking cessation and implementation strategies potentially feasible to scale up to more clinics upon the completion of the funded research, given realistic expectations regarding the resources that will be available in other clinics?

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

Specific for this FOA: As applicable for the type of project proposed (intervention design, intervention implementation, or hybrid of both):  How innovative is the proposed intervention(s) and, if not entirely new, is this intervention innovative in terms of substantial changes for the context of LDCT settings? Or, how innovative are approaches to the implementation of existing evidence-based smoking cessation interventions? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

Specific for this FOA:

Is the project interventional and comparative? Does the project test interventions to determine the key components and characteristics of a clinically effective smoking cessation intervention, or the key components and characteristics of an effective implementation strategy? Are the cessation interventions evaluated in terms of the rates of cessation and sustained abstinence (6-12 months after cessation) among current smokers undergoing screening?  Does the project assess cessation intervention fidelity, patient acceptance and engagement, patient reach (i.e., the absolute number, proportion, and representativeness of individuals who are willing to participate), cost, and the ease of delivery and feasibility (e.g., effects on clinic workflow)? Is the LDCT site an essential site for the delivery of the cessation intervention(s)?

Are the proposed interventions sufficiently well supported by the existing evidence and/or preliminary data? 

How realistic and comprehensive is the applicants' vision in terms of what training materials, data collection tools, and other technical resources may be needed as a package that would allow other institutions to implement the proposed interventions?

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

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?  

Specific for this FOA: Is the lung cancer screening facility sufficiently prepared to participate in the proposed research project? Are the LDCT clinics sufficiently characterized in terms of patient population, geographic setting, resources, space, personnel, knowledge, business plan, and/or other factors that distinguish LDCT settings?

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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) convened by the NCI, 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 Institute 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.
  • Programmatic priorities including the diversity of clinical settings in which interventions will be tested (including such aspects as: available patient volumes, their demographic characteristics, geographic settings, and/or types of healthcare organizations involved).
  • Compliance with resource sharing policies.
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

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 grantee’s business official.

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

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

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Stephanie R. Land, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6946
Email: landsr@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.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.

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