Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-AT-24-006: Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Complementary and Integrative Health ( NCCIH ) National Institute on Drug Abuse ( NIDA ) National Cancer Institute ( NCI ) Funding Opportunity Title Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed) U24 Resource-Related Research Projects Cooperative Agreements November 9, 2023 - Notice of NCCIH Technical Assistance Webinar for RFA-AT-24-006 "Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed)".

See Notice NOT-AT-24-025 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 213, 93.

279, 93. 866, 93. 393 Funding Opportunity 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 as well as to enable researchers to successfully generate more rigorous scientific evidence across a variety of research domains in both basic and clinical research.

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.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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). Required Application Instructions 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 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description 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.

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 ). 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.

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: 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. 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 ).

Organize annual meetings (e.g., annual investigator meetings). 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).

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.

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.

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 Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this NOFO. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NCCIH will commit up to $1 Million in total costs in FY 2025 to fund one award.

NIA will commit up to $100,000 per year in co-funding toward the single award. NIDA will commit $100,000 per year in co-funding toward the single award. NCI will commit $200,000 per year in co-funding toward the single award Application budgets need to reflect the actual needs of the proposed resource center and should not exceed $850,000 direct cost per year, excluding consortium F&A.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 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. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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. 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. 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: Director, Office of Scientific Review Division of Extramural Activities National Center for Complementary & Integrative Health (NCCIH) All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission 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. 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. 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. 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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The Specific Aims page should include: 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.

A summary of the general structure and governance of the Center. A summary of the expertise in place or to be recruited to develop each required core. 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: 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.

Required Core Components: The following subheadings should be included within the description of each Center core.

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 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 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.

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