Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

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.

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

It is critical that applicants follow the instructions in 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 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA), and National Center for Complementary and Integrative Health (NCCIH) invite Cooperative Agreement (U01) applications that propose a prospective cohort study to assess the benefits and harms of cannabis and cannabinoid use among adult cancer patients during active treatment. NCI, NIDA, and NCCIH are seeking well-designed prospective cohort studies of cancer patients with solid or hematologic tumors currently receiving treatment. Studies are expected to compare cancer patients who use cannabis/cannabinoids with cancer patients that do not use cannabis and/or cannabinoids. Research studies that include diverse populations by age, sex, race/ethnicity, tumor types, and/or geography and propose population-based recruitment strategies using cancer registries are strongly encouraged.

It is anticipated that the new prospective studies will provide critical evidence of the benefits and harms of cannabis and cannabinoids required to design and conduct clinical trials.

This FOA is published in parallel with RFA-CA-22-053 "Coordinating Center for Cannabis and Cannabinoid Use in Adult Cancer Patients During Treatment: Assessing Benefits and Harms (U24 Clinical Trial Not Allowed). Successful awardees from this FOA will work with the NIH program staff and the U24 coordinating center funded under the RFA-CA-22-053.

Key Terms for This FOA

Cannabis and Cannabinoids: In this FOA, the terms cannabis and cannabinoids refer to any cannabis plant (e.g., marijuana), cannabis-derived products/cannabinoids, tetrahydrocannabinol (THC), cannabidiol (CBD)-only products, prescription cannabinoids such as Dronabinol and Nabilone, commercially available as Marinol (dronabinol capsules), Syndros (dronabinol oral solution), and Cesamet (nabilone), or any other products made with or derived from cannabis.

Prospective Cohort Study: A longitudinal study that compares and follows a group of people who are exposed and unexposed to a factor of interest, in this case comparing cancer patients using cannabis and cannabinoid products to those not using these products and assessing health outcomes.

Cancer Patients in Active Treatment: Cancer patients enrolled during active treatment include those undergoing surgery and/or radiation and/or other systemic therapy, including those with recurrent/metastatic disease.

Coordinating Center: Includes the coordinating center funded through the companion RFA-CA-22-053.

Background

The US legal landscape of medical and nonmedical cannabis and cannabinoid (cannabis-derived products) use has changed dramatically over the past decade, with wide variation in state policies. Concurrently, the available delivery methods of these products have also undergone substantial changes and include edibles, oils, tinctures, topicals, and inhaled forms. These changes in legalization and types of cannabis and cannabinoid products have increased access and use among the general US population. Despite this increase in cannabis and cannabinoid use, research on its health effects, including both the potential benefits and harms, remains limited.

While most US medical oncologists regularly engage in discussions about cannabis and cannabinoid use with patients, few oncologists feel sufficiently informed to make recommendations. Nonetheless, recent surveys consistently demonstrate that at least a quarter of cancer patients use cannabis and cannabinoids for symptom management during their treatment. Cancer patients use cannabis and cannabinoids during treatment to manage common symptoms such as anxiety, loss of appetite, nausea, pain, and sleep disturbance. While many patients report beneficial effects, there is also potential for harms such as cardiac issues and cognitive impairment. In addition, three recent observational studies demonstrate that cancer patients using cannabis during immunotherapy were significantly more likely than those not reporting cannabis use to show a shorter time to tumor progression.

The rapidly increasing availability of cannabis and cannabinoid products, their delivery methods, and the dearth of information available on their harms and benefits during treatment, call for a rapid infusion of multiple studies addressing cannabis and cannabinoid use among cancer patients.

Research Objectives and Requirements

This FOA aims to address gaps in knowledge and build evidence of the types of products in use, frequency and dosage of use, and the benefits and harms of cannabis and cannabinoid use during cancer treatment. NCI, NIDA, and NCCIH are seeking well-designed prospective cohort studies of cancer patients with solid or hematologic tumors, currently receiving treatment, comparing those using with those not using cannabis and cannabinoids. Studies should include diverse populations by age, sex, race/ethnicity, tumor types, and/or geography.

Applicants responding to this FOA should be aware of the companion FOA (RFA-CA-22-053) for the U24 coordination center.

Specific Areas of Research Interest

Areas of research interest include, but are not limited to, the following:

• What adverse effects of cannabis and cannabinoid use are observed in cancer patients? Adverse effects may include, but are not limited to, somnolence, dry mouth, fatigue, increased appetite, dizziness, nausea, headache, euphoria, lightheadedness, cannabis use disorder, brain fog, falls cardiac issues, cognitive impairment, and respiratory problems.
• How is cannabis and cannabinoid use associated with improving cancer patients symptoms? How does dose, frequency of use, different types, delivery methods, and sources of cannabis and cannabinoid products influence symptoms? Symptoms may include, but are not limited to, anxiety, cachexia, depression, fatigue, lack of appetite, nausea, neuropathy, pain, sleep disturbance, and vomiting.
• How is cannabis and cannabinoid use associated with cancer patients use of medications and other complementary and alternative medicines to manage symptoms, persistent side effects, and functional deficits of their cancer or cancer-related treatments?
• What potential interactions (i.e., mitigating or enhancing effects) of cannabis and cannabinoid use are observed in cancer patients regarding cancer therapies and/or other medications or adjunct therapies used for symptom management?
• What are the biological effects of cannabis and cannabinoid use during cancer treatment? These may include biological mechanisms of effect potentially affecting cancer therapy, such as liver/kidney function and inflammatory markers.

Studies must include the following:

• Scientific justification of the research gaps to be addressed related to understanding the benefits and harms of cannabis and cannabinoid use among cancer patients in active treatment.
• Prospective cohort study design of cancer patients in active treatment comparing those who use cannabis/cannabinoids to those not using cannabis and/or cannabinoids. Cancer patients undergoing active treatment (surgery and/or radiation and/or other systemic therapy). Follow-up of cancer patients may continue beyond the active treatment period.
• Justification of the study population and sample size given the proposed science. If the participants are outside the US, justification needs to address relevance to the US population.
• Detailed information on the types and patterns of cannabis and cannabinoid uses among cancer patients, purpose of use, and associated outcome measures. This information should include the types and source of products used, the mode of administration as well as the frequency and dose, and to the extent possible, what active ingredients are included (e.g., THC to CBD, ratios between the two compounds). The collection of this information should be as detailed as possible and may include patient-report of cannabis and cannabinoid use, specific products used, and products sources (medical dispensaries and other sources).
• Detailed information on patient demographics, social determinants of health, clinical and disease characteristics, co-morbidities, and inpatient and outpatient cancer treatments and oral therapies should be obtained from medical (e.g., electronic health records and/or other medical records), and/or pharmacy records. Additional information can be obtained from patient reports.
• Patients use of medications and other complementary and alternative medicines used to manage symptoms should be obtained.
• Validated patient symptom surveys that measure the presence and severity of symptoms over time should be used. High-quality data should be collected using validated methods and instruments and evidence-based approaches (e.g., abstraction of detailed treatment data, NIH Common Data Elements, Patient-Reported Outcomes Measurement Information System [PROMIS]).
• Data collected from routine clinical monitoring (e.g., kidney and liver function, blood cell count).
• Measurement of cannabis use disorder through surveys or other techniques.
• Willingness to collaborate on collecting a core set of questions related to cannabis and cannabinoid use and other survey measures (e.g., health outcomes, patient-reported outcomes) in cancer patients in active treatment.
• If biospecimen assays are proposed, evidence of reproducibility and validity must be included in the grant application.
• Detailed data/resource sharing plans that are consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/) for Resource Sharing Plans as provided in SF424 Application Guide. The data sharing plan must describe the management and decision-making process that promotes rapid data sharing with the broad research community, the timeline for sharing, the repository where the data will be located, process for accessing data, and any limitations. The plan should also include steps for creating standard operating procedures, accessibility requirements, and review process for granting access to the research community and dissemination of that information. The data sharing plan will become a term and condition of award. Applicants are required to provide broad access to the data through controlled-access data repositories. Applicants are encouraged to consider NIH data repositories for sharing data with external investigators. Informed consent must include permission to share de-identified data with the broad research community and deposit to a controlled-access repository. If non-NIH repositories need to be selected, these must be publicly accessible or controlled access. (See www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html for a full listing of NIH repositories).

Studies are also strongly encouraged to consider the following

• Patient populations undergoing systemic chemotherapy and / or immunotherapy.
• Biospecimen collection to assess biological effects of cannabis and cannabinoid use during treatment beyond routine clinical assessments, for example inflammatory markers or potential drug interactions. Biological specimen analysis for THC and/or CBD levels are also permitted, but investigators will need to address the issues of current lack of measurement standards, legality status and confidentiality, and challenges with timing of specimen collection and cannabis and cannabinoids. If biospecimen assays are proposed, evidence of reproducibility and validity must be included in the grant application.
• Population-based recruitment strategies using cancer registries.

Additional Requirements

• Awardees are expected to work collaboratively with the coordinating center funded by RFA-CA-22-053 and NCI staff to move this research area forward.
• Awardees are required to work with the coordinating center to identify a core set of questions to be included in data collection across funded studies.
• Awardees are required to comply with all NIH data sharing policies (https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies).
• If applicable, investigators are expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources for the collection, processing, and storage of biospecimens (https://biospecimens.cancer.gov/bestpractices/).
• Applicants will be required to budget for in-person meetings at NIH for years 1,3, and 5. Meetings will take place annually (in-person years 1, 3, and 5; virtually in years 2 and 4), where awardees will discuss their progress, measures, and methodologic work. Additional virtual interim meetings will take place throughout the award period.
• Awardees are required to provide annual progress reports and descriptive data to NCI, including accrual, response rates, and vital status.
• When feasible, applicants should measure and report results using standard THC units. Please refer to Notice of Information titled Establishment of a Standard THC Unit to be used in Research (NOT-DA-21-049).

Program Structure

The program will include four new cohorts and a coordinating center to integrate efforts across the individual cohorts. Awardees are expected to be open to collaborative efforts, such as sharing of assessment measures (questionnaires, collection procedures, best practices), and incorporating a core set of questions, as appropriate given the study population, among the program participants. Members will be required to participate in annual meetings (in-person years 1,3, and 5 and virtual in years 2 and 4 of award period) for the exchange of scientific information across the cohorts. In addition, awardees are expected to participate in interim virtual meetings as appropriate and determined by NIH program staff and steering committee. The program will be governed by a steering committee composed of principal investigators from the funded cohorts, the coordinating center, and NIH program staff.

Awardees will be required to interact closely with the coordinating center, and NIH program staff to advance scientific research related to understanding the benefits and harms of cannabis and cannabinoids among cancer patients in active treatment, as outlined below.

• Scientific Interactions with Coordinating Center: Each cohort will collaborate with the coordinating center as required to share data collection instruments, measures, and resources; identify a core set of questions; discuss shared challenges; and, as appropriate, share protocols for the collection of biological specimens.
• Scientific Interactions with Steering Committee: The steering committee may establish work groups as needed for specific topics and / or emerging scientific opportunities that are shared across all the research of the cohorts. Members of work groups will include investigators from each cohort, coordinating center, and NIH program staff.

Program Governance

The steering committee will comprise the principal investigator (PI) of each cohort and the coordinating center, and NIH program staff. Though the steering committee will make recommendations, NIH program staff will have final authority to approve any proposed recommendations, and activities must comply with NIH, DHHS, and federal guidelines.

Additional details on the composition and functions of the steering committee are provided in Section VI.2, Cooperative Agreement Terms, and Conditions of Award.

Non-Responsive Applications

The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed:

• Clinical trials
• Studies not including human subjects
• Studies not enrolling patients under active treatment
• Studies that do not include a comparison group of cancer patients in active treatment not using cannabis and cannabinoids

Applicants are encouraged to contact NIH program staff to discuss the alignment of their proposed work with the goal of this FOA.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to

Kelly K Filipski, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6841
Email: [email protected]

Page Limitations

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

Instructions for Application Submission

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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) Project/Performance Site Locations

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

SF424(R&R) Cover

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Travel Budget: Applicants are required to budget funds for PD/PI(s) for travel to attend an annual grantee meeting at a location determined by NIH program staff in years 1, 3, and 5 of the grant period. In years 2 and 4 of the grant period, annual grantee meetings will be held virtually. The purpose of these meetings will be to bring together investigators to share common research areas and topics across studies and share knowledge, progress, and findings, and allow for rapid translation of results. In addition, the budget of the U01 is limited to $500,000 in direct costs per year.

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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

Specific Aims: All applications must include research aims to address the goals.

Research Strategy: Applicants must organize the Research Strategy into the subsections identified below. Applicants may include other sections as needed but must include the information requested below.

Sub-section A. Background and Significance:

• Justification of how the proposed research is relevant to addressing the goals of identifying the benefits and harms of cannabis/cannabinoid use during active cancer treatment.
• Justification explaining how the proposed research addresses a pressing need or evidence gap pertaining to understanding the benefits and harms of cannabis and cannabinoid use in cancer patients, as identified in the literature.
• Explanation of how information gained from the project, if successful, will inform future interventions, clinical guidelines, or patient management strategies to improve health outcomes for cancer patients.

Sub-section B. Preliminary Data

• Summarize appropriate preliminary data, including the ability to recruit cancer patients.
• Describe prior experiences with collaborative research projects.

Sub-section C. Approach

• Describe methods that will be used to accomplish specific aims.
• Describe procedures to identify, recruit, and enroll patients and methods to achieve diverse and inclusive participation in the research including the collection of disease characteristics (e.g., cancer type, tumor biomarkers), individual patient characteristics (e.g., comorbidities, socio-economic status [SES]), and patient health outcomes (e.g., symptoms).
• Describe the proposed assessment measures of exposures (e.g., cannabis and cannabinoids, cancer therapies, symptom management medications) and outcomes (e.g., symptoms) and evidence of their validity and reproducibility.
• If biospecimen assays are proposed, describe evidence of reproducibility and validity.
• Describe the analytic plan, including calculations for sample size and power analyses for each aim, if appropriate.

Sub-section D: Data Sharing and Dissemination

• Applicants must provide a detailed plan for the facilitation of data and resource sharing (see Resource Sharing Plan).

All applicants should state their willingness to collaborate with the coordinating center and share information and resources among the U01 awarded projects.

Letters of Support: Applicants must include letters of support from collaborating entities that are essential to the mission of the work 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.

The following modifications also apply:

Applicants must provide a detailed plan for the facilitation of data and resource sharing that is compliant with NIH data sharing policies (https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies), including the NIH Genomic Data Sharing Policy (https://datascience.cancer.gov/data-sharing/genomic-data-sharing). The data/resource sharing plans must be consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/). Instructions for the Resource Sharing Plan are provided in the SF424 Application Guide. The data sharing plan will become a term and condition of award.

The following modifications also apply:

• The data sharing plan needs to include a description of the management and decision-making process that promotes rapid data sharing with the broad research community and describe how data will adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable).
• The data sharing plan needs to address the timeline for the data to be shared after each round of data acquisition.
• The repository where the data will be located, process for accessing data, and any limitations need to be described in the data sharing plan. Data collected under support from this FOA are expected to be widely shared through NIH-designated data repositories. Informed consent must include permission to share de-identified data with the broad research community and deposit to a controlled-access repository. If non-NIH repositories need to be selected, these must be publicly accessible or controlled access. (See www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html for a full listing of NIH repositories).
• The data sharing plan needs to describe the steps for creating standard operating procedures, accessibility requirements, and the review process for granting access to the research community, and dissemination of that information.
• The data sharing plan will become a term and condition of award.
• Applicants are required to maintain a website that details the procedure for external investigators requesting and obtaining data; procedures and criteria for access must be compliant with NIH data sharing policies (https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies). A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI.

Appendix:

Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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 NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by 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 will receive a written critique.

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.

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable US Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, US Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR 200, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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 for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Defining the overall research objectives;
• Determining approaches, designing protocols, and overseeing the conduct of the research of the grant;
• Overseeing the conduct of the U01 research and ensuring its scientific rigor;
• Ensuring compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
• Adhering to NIH policies regarding intellectual property, data release, and other policies that might be established during the U01 grant;
• Submitting updates to the U24 coordinating center and NIH on progress and problems;
• Participating as voting member(s) of the steering committee;
• Implementing guidelines and procedures developed by the coordinating center;
• Participating in teleconferences with NIH program staff, as needed;
• Attending meetings to location determined by NIH program staff;
• Retaining custody of and having primary rights to the data, technologies, and software developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies; and
• The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to NCI (NIH) for the performance and proper conduct of the research supported by the U01 award in accordance with the terms of the award.

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

One or more designated NIH program staff members will have substantial involvement as project scientist(s) for the U01 cohort.

Additionally, an NIH program director acting as program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The responsibilities of substantially involved NIH Program Staff members will include the following activities:

• Participating as voting members in the steering committee;
• Advising on innovative approaches for sharing results from the U01 to key stakeholder organizations (e.g., professional societies, community engagement groups) in user-friendly formats (e.g., briefs, summaries) that extend beyond the traditional peer-reviewed publications or scientific conference presentations;
• Participating in teleconferences with the PDs/PIs and key personnel of the U01s to monitor progress;
• Providing scientific input on the U01, including a core set of data topics collections, biological samples collections, and methodological and statistical considerations; participant recruitment, enrollment, and retention; and data analysis and interpretation of study findings;
• Along with the coordinating center, participate in organizing and coordinating recipient meetings (in-person and virtual meetings);
• Participating in work groups;
• Contributing, as appropriate, to scientific manuscripts and other scientific and scholarly activities (e.g., oral presentations, poster presentations) resulting from the U01 grant;
• Facilitating collaborations between the recipients and other NIH-sponsored programs investigators, or organizations;
• Assisting with the coordination of efforts that may contribute to the projects goals;
• Organizing and participating in webinars with PDs/PIs to monitor progress and facilitate cooperation;
• Monitoring progress of the projects towards meeting goals of the U01 grant; and
• Stimulating interactions among recipients.

Areas of joint responsibility include the following:

The steering committee will serve as the governing body formed by the U01 recipients funded under RFA-CA-22-052 and the U24 recipient funded under RFA-CA-22-053 together with the NIH.

The steering committee will consist of the following voting members:

• The PDs/PIs from each cohort U01 award (one vote per cohort);
• The PDs/PIs from the coordinating center (one vote for the coordinating center);
• The NIH-assigned project scientist(s), who collectively will have one vote; and
• A chair of the steering committee, who will be selected at the first meeting. The chair will serve a term of 12 months.

The steering committee U01 recipients, the U24 coordinating center, and the NIH program staff will meet as needed virtually throughout the award period. Formal annual meetings will take place, with in-person meetings held in years 1,3, and 5 at locations selected by the NIH program staff and virtual meetings held in years 2 and 4.

The steering committee may decide to establish work groups for specific purposes. The NIH project scientists will serve on such subcommittees, as they deem appropriate.

The main responsibilities of the steering committee will include the following elements:

• Addressing and coordinating aspects relevant to research and the coordinating center;
• Developing, as needed, overall policies and processes applicable to all recipients;
• Setting agendas for what policies and procedures should be developed that enable the evaluation of cannabis and cannabinoid use in cancer patients in active treatment;
• Attending meetings to review progress across the U01 awarded projects;
• Identifying scientific writing groups for manuscripts and oral and poster presentations at professional societies and scholarly meetings;
• Establishing work groups as needed; and
• Facilitating communications among recipients (e.g., to share ideas, discuss solutions to technical issues, resolve logistical problems, shared common challenges, etc.).

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and NIH may be brought to dispute resolution. A three-member dispute resolution panel will be convened, consisting of one NIH designee and two designees with expertise in the relevant area, chosen by the other two. 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.

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

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: http://grants.nih.gov/support/ (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]

Kelly K Filipski, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6841
Email: [email protected]

Andrew N. Freedman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6697
Email: [email protected]v

Evan Sullivan Herrmann
National Institute on Drug Abuse (NIDA)
Phone: 301-443-1428
E-mail: [email protected]

Sekai Chideya-Chihota
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-552-2994
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Dawn M. Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-6291
E-mail:[email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

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.

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.