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 Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Purpose

The purpose of this notice of funding opportunity (NOFO) announcement is to support the development and maintenance of a Resource Center for Cannabis and Cannabinoid Research through a cooperative agreement funding mechanism (U24). Such a Center will address challenges and barriers to conducting research on cannabis and its constituents. The Center is expected to be a focal point for researchers entering the cannabis research space and to support the development and establishment of research tools and studies that will improve upon and eventually change the landscape of cannabis research. Overall, the Center will facilitate research advances through synergistic interactions among experts in relevant commercial, basic science, clinical, and regulatory areas both within the Center itself and in collaboration with the extramural community.

Background

Cannabis and its constituents have a wide array of pharmacologic actions that have propelled interest from health care providers and the public on the medicinal effects of cannabis products. As of Fall 2023, 38 states and the District of Columbia have legalized cannabis use for broad medical purposes, reflecting rapidly growing interest in cannabis use for its therapeutic potential. The U.S. Food and Drug Administration (FDA) has also approved several natural and synthetic cannabinoids for specific health conditions (e.g., EPIDIOLEX [cannabidiol] for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis). Despite widespread availability and established pharmaceutical potential, there are still significant barriers to conducting research, which has resulted in insufficient data on the basic mechanisms, safety, abuse potential, and efficacy for many of the cannabinoids and other constituents of cannabis. To date, several National Institutes of Health (NIH) Institutes and Centers (ICs) have undertaken efforts to leverage the therapeutic opportunities associated with cannabis. Selected examples of NIH-issued NOFOs include Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes (RFA-AT-19-008, R01; RFA-AT-19-009, R21; NOT-AT-20-002, NOT-AT-22-027), Cannabis and Cannabinoid Use in Adult Cancer Patients During Treatment: Assessing Benefits and Harms (RFA-CA-22-052, U01), and Registry of Medical Cannabis Use and Health Outcomes (RFA-DA-23-011, UM1). NIH has also conducted workshops and recently created an NIH-wide cannabis/cannabinoid research funding opportunity webpage (see NIH-Supported Research on Cannabis, Cannabinoids, and Related Compounds).

Objectives and Scope

Over the last several years, NCCIH, in collaboration with other NIH ICs, organized several annual investigator meetings to discuss the progress and challenges of cannabinoids and terpene research in the context of pain. During annual meetings of the investigators who are conducting these projects, several challenges were highlighted as major barriers to productive research efforts. In 2022, NCCIH published a request for information (RFI, NOT-AT-22-026), to gather more detailed and comprehensive information about scientific interests and barriers to research from investigators conducting research in the field. Information gathered under the RFI identified barriers that included Schedule 1 Status designation for cannabis, challenges in obtaining and maintaining Drug Enforcement Administration (DEA) registrations, issues related to Investigational New Drug (IND) applications, limited and inconsistently documented studies, lack of validated measures, the increasing diversity of cannabis products, and lack of medical education on cannabis for health care providers. To address the challenges raised in the RFI, this NOFO proposes the formation of a comprehensive Resource Center for Cannabis and Cannabinoid Research intended to reduce barriers to conducting research on cannabis and its constituents to enable researchers to successfully generate more rigorous scientific evidence across a variety of research domains in both basic and clinical research.

Required Core Components

The Center will be supported through a cooperative agreement and will serve as a comprehensive resource for investigators involved or interested in cannabis research. Applications submitted under this NOFO are expected to propose and describe in detail the Center’s three core components: a Regulatory Guidance Core, a Research Standards Core, and a Research Support Core. Needs associated with activities for each core (with the exception of administration of seed funding, which must be included in the Research Support Core) could include, but are not restricted to:

Regulatory Guidance Core

• Establish a policy clearinghouse to consolidate and link to existing DEA/FDA guidance.
• Organize regular meetings with DEA/FDA to receive updates regarding regulatory information relevant to researchers.
• Provide summaries and updates on policy changes to a centralized Center webpage on policy changes related to the regulatory environment surrounding cannabis research for the extramural community.

Research Standards Core

• Identify and disseminate information on high-quality cannabis research products and provide guidance on matching specific cannabis product vendors to the research objectives of investigators utilizing the Center.
• Develop research standards and metrics to enhance the rigor of chemical analysis of complex cannabis products to improve the reproducibility of research.
• Build a repository of best practices (e.g., reagents, standards, survey measures, data elements, and analytical methods), including the 5 mg tetrahydrocannabinol (THC) standard unit for measuring and reporting research results (NOT-DA-21-049).

Research Support Core

• Organize annual meetings (e.g., annual investigator meetings).
• Use social media to transmit scientific information.
• Organize and convene webinar series on topics that reflect Center core activities in regulatory guidance, research standards, and research support.
• Organize and convene both virtual and hands-on events such as workshops at meetings, summer institutes, and grant writing assistance and workshops.
• Identify and disseminate early career NIH reviewer opportunities.
• Administer seed funding for registration support and proposal development (see seed funding description below and Section IV. Application and Submission Information, R&R Budget and R&R Subaward Budget sections, for more information).

Seed Funding: The Research Support Core must budget funds for registration support and proposal development through the issuance of seed funding to the appropriate research community. Seed funds are intended to support non-research regulatory activities to reduce barriers to conduct future research projects within the field, in line with the stated interests of the NIH partner ICs. Regulatory requirements often impede the progress of research proposal development. Seed funds, therefore, provided by the Research Support Core, must serve to reduce barriers to research within the field. Examples include costs associated with obtaining a Schedule I DEA registration or other relevant federal regulatory requirements, and associated equipment and materials needed for storing and monitoring the research materials, or proposal development and administrative activities to conform with regulatory requirements. The Resource Center must provide a formal plan to solicit, review, and select/prioritize requests for seed funding, and to evaluate progress and outcomes, in line with the RFA priorities. Applicants must describe the type and focus of potential seed funding projects that would be solicited; however, descriptions of actual projects should not be included in the application. Researchers associated with the Resource Center itself may be considered for seed funding, but priority should be given to researchers from a broader range of locations and institutions. The selection of subaward projects will be made in consultation with the NIH project scientist(s) and approved by the NIH program officer(s). The details of the full governance structure are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award.

Additional Requirements and Considerations for Seed Funding:

• Seed funding projects may not exceed $50K total costs per year, regardless of the number of awards issued. Projects requesting more will be reviewed on a case-by-case basis.
• Applications may consider starting seed funding in Year 2.

The following types of seed funding activities are not responsive to this NOFO and will not be reviewed:

• Traditional investigator-initiated and highly focused research projects (best supported by the R01, R21, R61/R33, P01, or R03 activity codes).
• Core (or related) services to supplement the budgets of existing R01-type efforts.
• Investigators seeking support for scientific meetings should use PA-18-648 NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed).
• Investigators seeking support for pre- and postdoctoral research training programs should use PA-20-142 Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32).
• Investigators who only seek to create research education activities should use the R25 funding mechanism.

Specific Seed Funding Activities within scope of the NOFO sponsors

Participating NIH ICs will commit all funds towards the issuance of one Center award, for which seed funds dispersed by the Center must serve to reduce barriers to research within the field. The following is specific language describing seed funding activities that are within scope for the participating NIH ICs, for seed funds dispersed by the Resource Center for Cannabis and Cannabinoid Research.

National Center for Complementary and Integrative Health (NCCIH)

• Promote approaches and best practices to support research on the effects of minor cannabinoids and terpenes in the cannabis plant as it relates to pain and/or nociception.
• Promote approaches and best practices to support research on the mechanisms by which minor cannabinoids and terpenes may affect pain pathways, including cellular and molecular signaling pathways, neuroimmune interactions, or other innovative regulatory pathways related to pain.
• Promote approaches and best practices to support research on the interaction between the microbiome and minor cannabinoids or terpenes.
• Promote approaches and best practices to support research on how specific terpenes may influence potential analgesic mechanisms of understudied minor cannabinoids.
• Promote approaches and best practices to support research on multimodal approaches to analgesia that include minor cannabinoids and terpenes.

National Institute on Drug Abuse (NIDA)

• Promote approaches and best practices to develop and validate standard measures.
• Develop approaches and promote best practices to support research on the effects of cannabis/cannabinoid exposure on brain structure, function, and development prenatally and throughout the lifespan, as well as other health and social outcomes.
• Develop approaches and promote best practices to evaluate the therapeutic potential of cannabis/cannabinoids (alone, or in combination with other treatments) for pain, substance use disorders, and substance use comorbidities, such as HIV.

National Institute on Aging (NIA)

• Promote approaches and best practices (e.g., recruitment and retention strategies, population-specific measurement tools, other culturally appropriate considerations) to support research in diverse and understudied populations across the lifespan, including older adults and those with cognitive impairment.
• Develop and validate standard measures and promote best practices to support research on the effects of cannabis/cannabinoids in the context of aging, including but not limited to understanding mechanisms of cannabis and its constituents in the setting of pain and/or nociception, age-related cognitive decline and/or impairment, Alzheimer’s disease and Alzheimer’s disease related dementias, weight loss and/or cachexia, sleep, or conditions in palliative care settings, and in relation to multiple chronic conditions and polypharmacy.
• Develop and validate standard measures and promote best practices to gain a deeper mechanistic understanding of cannabinoid signaling and changes in signaling with aging to enable development of therapeutics that can benefit health across the lifespan.

National Cancer Institute (NCI)

• Promote generation of scientific evidence and best practices to support the planning and execution of cannabis and cannabinoid clinical trials in cancer patients and survivors (e.g., validation of measurement tools, addressing issues tied to IND applications, enhancing diversity of cannabis products for research purposes).

Milestones

The success of the project will be facilitated by the adoption of clear, quantitative milestones with realistic and efficient timelines. Applications must include proposed milestones for each year of requested support, which will be evaluated as part of the review process. The milestones and timeline should include the timing and quantity of dissemination of the resource to the cannabis research community. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn before review. The final version of milestones will be agreed upon at the time of award. If justified, future year milestones may be revised based on data and information obtained in the current year.

Structure and Governance

The organizational framework for the Resource Center for Cannabis and Cannabinoid Research must include three major components, described above, and is expected to promote interaction across the cores. Please see Section VI.2, Cooperative Agreement Terms and Conditions of Award, for further detail.

Scope

Applications that include the following topics will not be considered responsive to this RFA and will be withdrawn without review:

• Projects that lack required core components of the Center (i.e., a Regulatory Guidance Core, a Research Standards Core, and a Research Support Core).
• Projects proposing basic or clinical research using a cannabis product. Such applications should consider NOT-AT-22-027 instead.

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 NOFO.

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 Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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 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 their 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

Jessica McKlveen, PhD
Director, Office of Scientific Review
Division of Extramural Activities
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-8018
Email: [email protected]

Page Limitations

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

The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The Resource Center should not exceed $850,000 in total direct cost per year. A minimum of $300,000 and a maximum of $400,000 in direct cost on average should be budgeted each year for seed fund subawards.

R&R Subaward Budget

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

Seed funds will be distributed in the form of subcontracts to the third-party researcher's institution. Seed fund subawards from the Resource Center must be based on Fixed Amounts, as described in Section 8.1.2.11 of the NIH Grants Policy Statement. Seed funding projects may not exceed $50K total costs per subaward per year, regardless of the number of awards issued. If all partner ICs would agree, the unused seed fund allocation may be rebudgeted to support other activities highly relevant to the mission of the Resource Center.

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:

The Specific Aims page should include:

1. A summary of the goals for the proposed Resource Center for reducing barriers to research in the cannabis research field within the context of the required Regulatory Guidance Core, Research Standards Core, and Research Support Core.
2. A summary of the general structure and governance of the Center.
3. A summary of the expertise in place or to be recruited to develop each required core.
4. Within the required three-core framework, a summary of services proposed for each core.

Research Strategy: The Research Strategy should consist of the following sections:

1. Overall Goals and Significance: The proposed application should describe the significance of the proposed Resource Center in addressing barriers to conducting research on cannabis. The Resource Center should present metrics and other evidence to demonstrate past and/or future use, utility, and scientific impact.
2. Structure and Governance: The Center should document processes for developing terms of use, a management plan for coordination across institutions for applications spanning multiple institutions, and how the proposed activities will effectively engage participating institutions.
3. Required Core Components: The following subheadings should be included within the description of each Center core.

Regulatory Guidance Core

• Core objectives
• Expertise in place to manage core activities
• Milestones and deliverables
• Methods and strategies to achieve core objectives
• Timeline to achieve core objectives
• Assessment of core impact

Research Standards Core

• Core objectives
• Expertise in place to manage core activities
• Milestones and deliverables
• Methods and strategies to achieve core objectives
• Timeline to achieve core objectives
• Assessment of core impact

Research Support Core

• Core objectives
• Expertise in place to manage core activities
• Milestones and deliverables
• Methods and strategies to achieve core objectives
• Timeline to achieve core objectives
• Assessment of core impact
• A description of a process for soliciting, reviewing, rating, and supporting applications deemed appropriate for seed funding

Applicants must describe their strategy for reducing barriers to research in the field within the context of the three required cores and describe the process for soliciting and providing seed funding to qualified applicants. The success of the project will be facilitated by the adoption of clear, quantitative milestones with realistic and efficient timelines. Applications must include proposed milestones for each year of requested support, which will be evaluated as part of the review process. The milestones and timeline should include the timing and quantity of dissemination of the resource to the cannabis community. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn before review. A final version of milestones will be agreed upon at the time of award. If justified, future year milestones may be revised based on data and information obtained in the current year.

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.

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 application forms packages.

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

• 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.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply 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 Section 7.9.1 Selected Items of Cost.

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 NOFO 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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 NCCIH, in accordance with NIH peer review policies and practices, 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 NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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 2.4.4 Disposition of Applications.

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 NOFO 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 Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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

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

The governance structure of the U24 Resource Center for Cannabis and Cannabinoid Research will consist of the following:

1. Bidirectional communication between the funded Center and NCCIH staff. The Resource Center’s progress will be conveyed to senior NCCIH leadership (the NCCIH director, NCCIH division director, and NCCIH branch chief) via the Center’s program officer in consultation with the NIH assigned project scientist (see description of NIH program officer/project scientist duties below). A Center Steering Committee (SC; comprised of the PIs and NCCIH/NIH subject matter experts [SMEs]) will oversee the evaluation of the Center and make recommendations for major changes or actions post award through voting by the SC members. The Center lead PI, each of the core PIs, and one SME per partner IC would have voting rights.
2. The SC chair (or co-chairs) is responsible for organizing the quarterly SC meetings and developing the meeting agenda. The program officer or SC chair may request more frequent SC meetings if necessary.
3. The first year SC chair may be appointed by the program officer/NCCIH. The SC chair (or co-chairs) are responsible for organizing quarterly SC meetings and developing the meeting agenda. The program officer or SC chair may request more frequent SC meetings if necessary.
4. Thereafter, a SC chair (or two co-chairs) will be nominated and elected every 12 months through voting by the SC members. The program officer/NIH may provide a tie-breaking vote if necessary.

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

• Developing objectives, approaches, and strategies to build the Center.
• Defining general structure and governance of the Resource Center with well-delineated roles and responsibilities.
• Designating investigators to serve as members on an SC and other subcommittees, as appropriate.
• Attending quarterly (or as needed) virtual SC meetings.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined below in the "NIH Staff" section. The PD(s)/PI(s) will be expected to maintain close communications with the NIH project scientist(s) and, where appropriate, the program officer(s). The project scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Establishing and chairing a Center SC to coordinate and manage the Center activities. The SC will include all core leads. The PD(s)/PI(s) may name additional investigators to serve as members of the SC and subcommittees, as appropriate, and must coordinate regular meetings.
• Managing and coordinating project activities scientifically and administratively at the recipient institution and with any collaborating institutions.
• Ensuring that all data and information are disseminated according to the FAIR principles.
• Developing and proposing milestones that will be achieved during the project period.
• Updating goals and milestones at the time of award and provide summaries of progress toward those goals, including the Project Management Plan, at least yearly, as requested by NIH.
• Collaborating and communicating effectively with NIH and across the NIH program official to achieve project goals.
• Participating in regular discussions with the NIH staff.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH and with the approved Data Management and Sharing Plan.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• NIH will assign a program officer(s) who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program officer(s) will approve the selection of seed funding projects.
• NIH may designate additional staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another project scientist(s) or analyst, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study, or who may assist in the coordination of activities across multiple sites.
• Acting as the contact point for all facets of the scientific interaction with the recipient.
• Retaining overall programmatic responsibility for the award, including normal program stewardship and review of the scientific progress of each of the Center cores.
• Providing advice on the management and technical performance of the projects and cores.
• Convening the first meeting of and subsequently participating in the SC that oversees study conduct. The NIH project scientist or designee will be a full participant and voting member of the SC and, if applicable, subcommittees.
• Will be responsible for establishing an external advisory committee (EAC), in consultation with the PD(s)/PI(s) and working with the PD(s)/PI(s) to coordinate regular EAC meetings. The EAC will be composed of the project scientist, who will serve as a voting member, and up to five external advisors with appropriate expertise to provide advice relative to the Resource Center as well as make recommendations to NIH regarding progress, priorities, and modifications for the Center cores. The EAC will serve as the primary advisory body of the Resource Center, and NIH program officials will rely on the EAC for objective evaluation of the program.
• NIH staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
• NIH staff will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the study objectives.
• NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting.
• NIH staff will make recommendations to NIH for continued funding based on performance and compliance with the terms and conditions of the award.
• An agency program official(s) or IC PD(s) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The EAC will:

• Monitor progress of the project core(s).
• Evaluate the effectiveness of the Center PD(s)/PI(s), and of the Center as a whole.
• Identify problems and suggest possible solutions, especially with respect to effective focus on scientifically meritorious, critical and significant research, optimal allocation of resources, and synergy within the Center, and between the Center and extra-Center collaborators.
• Make recommendations to NIH staff about priorities and directions for the Center.
• The EAC’s evaluations and recommendations, in the form of a written annual report, are to be submitted to the project scientist and the Center PD(s)/PI(s) and will be used by the project scientist and the Center PD(s)/PI(s) to guide and direct the program. Subcommittees with additional ad hoc advisors may be established by the EAC as necessary in order to meet its planning, priority setting, and evaluation responsibilities. Recipient generally will be expected to accept and implement the recommendations of the EAC; in those situations where implementation of the recommendations is not feasible, the Center PD(s)/PI(s) must provide a thorough explanation and rationale to relevant NIH staff.
• The first EAC meeting will be convened by the recipient within 3 months of the award date. The EAC will then meet annually 3 months before the anniversary of the Center award date.
• The EAC will take minutes of all EAC meetings, which will be sent to NIH staff within 30 days of the meeting and will be included in the annual progress report of the Center.

Collaborative Responsibilities:

• Evaluating the Center's progress in meeting its goals and the continued significance of those goals for the design of a future clinical trial
• Ensuring appropriate and necessary coordination with related projects. Establishing an SC. The SC chair will not be an NIH staff member. The SC may add additional members. Other government staff may attend the SC meetings if their expertise is required for specific discussions.
• The SC will be composed of the PD(s)/PI(s) and other key personnel as deemed necessary, including core leads and the NIH project scientist or designee. An initial meeting of the SC will be convened early after award by the NIH project scientist or designee. The final structure of the SC will be established at the first meeting. The NIH project scientist or designee will have voting membership on the SC, and as appropriate, its subcommittees. The NIH project scientist will serve as an ex officio member of the SC, which will meet at least twice yearly.
• The SC has primary responsibility to design research activities, establish priorities, establish and maintain quality control, review progress, coordinate and standardize data and resource management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the SC. The SC will document progress in written reports to the IC program officer and will provide periodic supplementary reports upon request.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee (SC) chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 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.

4. 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 NOFOs 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 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: https://www.era.nih.gov/need-help (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: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Patrick C. Still, PhD
Program Director
Basic and Mechanistic Research Branch
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-682-1895
Email: [email protected]

Heather L. Kimmel, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5899
Email: [email protected]

Kate Castro, RN, MS, AOCN
National Cancer Institute (NCI)
Telephone: 240-276-6834
Email: [email protected]

Jessica McKlveen, PhD
Director, Office of Scientific Review
Division of Extramural Activities
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-594-8018
Email: [email protected]

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

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Kathleen Moy
National Institute on Aging (NIA)
Phone: 301-827-2856
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
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 2 CFR Part 200.