RFA-DA-27-015-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of

RFA-DA-25-056

Related Notices

Funding Opportunity Number (FON)

RFA-DA-27-015

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.279

Notice of Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to establish a Center that educates and mentors researchers in formal product development for new substance use disorder (SUD) pharmacotherapeutics and to advance the best concepts through initial experiments via technical and financial support.

Funding Opportunity Goal(s)

To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcome, including HIV/AIDS. To support research training and research scientist development.

Key Dates

Posted Date

May 21, 2026

Open Date (Earliest Submission Date)

August 30, 2026

September 30, 2026

Not Applicable

Not Applicable

July 2027

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).

Expiration Date

October 01, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates 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

Background Translating novel ideas from the laboratory into clinically viable commercial products presents numerous challenges. Many academic researchers, particularly those working on novel substance use disorder (SUD) pharmacotherapeutics, may lack awareness of the initial steps required to transition a discovery from the lab to the market. Often, they do not have the resources to explore formal product development and commercialization pathways while maintaining a productive lab. Furthermore, training in product definition, a crucial first step in translating a promising idea, is limited for these researchers. The lack of exposure to training and resources supporting early product development can result in potential new treatments for SUD never progressing beyond the lab bench.

There is a pressing need for additional support in technical development within the context of translation. This support will facilitate the transformation of pioneering ideas into tangible biomedical products. Previous National Institute on Drug Abuse (NIDA)-supported initiatives in early translational research have shown that drug addiction researchers are eager to acquire formal product development skills and access technical expertise and support. Consequently, this notice of funding opportunity (NOFO) aims to establish a Center to educate academic researchers with an interest in developing pharmacotherapeutics for SUD in product concept development and in the design of initial early-stage experiments to demonstrate technical and commercial feasibility, as well as providing mentorship and funding to support the most promising ideas.

Objectives The objective is to establish a Center that educates and mentors researchers in formal product development for new SUD pharmacotherapeutics. The Center will also advance the best concepts through initial experiments via technical and financial support.

The Center has the primary responsibility of designing and executing the activities as defined in this section. The Center will be responsible for developing achievable program plans, tracking all activities and processes, and adhering to budget and approved reporting plans.

1) Outreach and Networking: The Center is required to actively engage in extensive outreach to identify and recruit program participants. These participants should be academic researchers interested in transforming their research discoveries into new SUD pharmacotherapeutics.

Targeted participants are drawn to the program due to the opportunity to gain training in formal product development, secure seed funding for early feasibility studies, validate their ideas, and enhance their ability to secure additional funding for project development. It is expected that participants will come from a variety of backgrounds and possess diverse expertise.

The Center is responsible for managing an application process for the program. This includes evaluating applications based on admission criteria and, in collaboration with NIDA, selecting the most suitable candidates to participate in the program. Furthermore, the Center is tasked with establishing a network of mentors and experts to serve as program faculty. This network will provide guidance and support to the participants throughout the program.

The Center must:

a) Formulate an outreach strategy to identify interested researchers.

b) Recruit researchers to participate in and attend program training.

c) Establish a network of mentors and experts such as drug developers, investors, regulatory experts, and intellectual property experts to serve as program faculty, providing necessary expertise, advice, and feedback to program participants.

2) Drug Development Training and Education: The Center must develop a customized curriculum to educate and train academic researchers in SUD drug development. The Center will be responsible for administering this curriculum.

The Center is strongly encouraged to include a 2- to 3-day in-person session as part of the course, allowing participants to connect with faculty, mentors, and additional experts within the Center’s network. The Center is responsible for providing mentorship to participants and helping them validate and define clinical needs for their proposed product, generate and refine their idea, define the target product profile (TPP), consider regulatory and ethical aspects, and design early-stage experiments that demonstrate the technical and commercial feasibility of their ideas.

The Center must:

a) Develop a curriculum to educate researchers about the formal SUD drug development process.

b) Deliver the curriculum to the cohort through various modes such as virtual and in-person workshops, webinars, and other training and communication methods.

c) Provide mentorship to program participants, both individually and on a cohort basis, in designing experiments that demonstrate the technical and commercial feasibility of translating their research discoveries and in the importance of ensuring all the necessary intellectual property arrangements.

3) Preclinical Study Support: The Center is tasked with developing a solicitation process to distribute the seed funding through subawards to program participants. The Center also assists participants in submitting concept proposals to secure this funding. The Center manages the evaluation of these proposals, using criteria such as addressing unmet needs, the novelty of the approach, and the potential of a subaward to advance the technology towards clinical application and/or licensure, among others. Each proposal from program participants should describe a single key preclinical study that could be conducted in a period of performance of less than 6 months and that would provide experimental results to determine whether further advancement of the concept is technically feasible and commercially viable.

In collaboration with NIDA, the Center selects proposals for subawards. Only a subset of participant proposals should be selected to receive a subaward. It negotiates with participants on the scope of work for these subawards and provides technical advice to refine study protocols. Funds must be allocated to tasks that advance the technology towards clinical application and must comply with NIH guidelines. The Center then manages the subawards, provides technical advice to the subawardees, communicates with the subawardees and NIDA on progress, and obtains the final report on the studies from subawards.

The Center must:

a) Develop a process to solicit, evaluate, and nominate preclinical research studies from program participants for initial (seed) funding.

b) Provide technical assistance to selected program participants to help finalize their experimental protocols. Early-stage experiments may include validating the drug target, demonstrating the mechanism of action, identifying candidate compounds, optimizing drug properties, conducting in vitro experiments, and conducting preliminary in vivo studies.

c) Issue and manage subawards for these early-stage experiments.

d) Provide project management support and technical advice to the subawardees, ensuring compliance with all applicable NIH guidelines and policies, and monitor the progress of the experiments.

4) Administrative Requirements: The Center must:

a) Submit all required technical reports.

b) Maintain fiscal and programmatic systems to ensure accountability and performance tracking.

c) Issue and oversee subawards in a timely and responsible manner.

Applications Not Responsive to this NOFO The following types of studies are not responsive to this NOFO and will not be reviewed:

Projects solely focused on alcohol use disorder.

Special Considerations NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

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

Section II. Award Information

Funding Instrument

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

New

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDA intends to commit $3 million to fund one award in FY 2027.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

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)

Foreign Organizations/International Collaborations

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

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

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

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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 How to Apply - Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Required

Required

Required

Required

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Follow standard instructions.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:

Describe an overall administrative plan appropriate for effective management of the Center's structure. Center leadership, including PD(s)/PI(s), must demonstrate operational, business, and scientific expertise with a documented track record of successfully transitioning biomedical products.

Overall Research Strategy:

Applicants must:

Letters of Support:

Provide all letters of support that are appropriate for this project, including any letters of support from institutional officials and sources of non-federal resources.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative Core When preparing your application, use Component Type Admin Core.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Admin Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Admin Core) Follow standard instructions.

Research & Related Other Project Information (Admin Core) Human Subjects: Answer only the “Are Human Subjects Involved?” and “Is the Project Exempt from Federal regulations?” questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Applications that include additional attachments in this component will be withdrawn.

Project /Performance Site Location(s) (Admin Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Admin Core)

Budget (Admin Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Admin Core) Specific Aims: Describe the specific aims to address coordination, management, as well as evaluation and continuous improvement in quality and efficiency.

Research Strategy: The Administrative Core serves as the central element of the Center. This Core is responsible for leadership, management, and oversight of the other Cores. Describe how the Administrative Core will effectively coordinate interactions and collaboration of cores, and investigators, as well as coordinate activities with NIDA Science Officers. The application should clearly define the management plan for the proposed Core, and how it will support achievement of the proposed goals and milestones. Applicants should also describe the center's approach to managing intellectual property.

The PIs/PDs will work together with NIDA to make all major decisions. Applications are advised to include the following in the Research Strategy:

Describe the roles and responsibilities of key technical and administrative members of this Core. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan to describe the management roles of each PI/PD and how conflicts will be resolved. Applicants should explain the Administrative Core's conflict of interest policy.

Letters of Support: Only letters of support specific to Administrative Core should be attached to this section.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

PHS Human Subjects and Clinical Trials Information (Admin Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

Outreach and Networking Core When preparing your application, use Component Type Outreach Core.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Outreach and Networking Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Outreach and Networking Core) Follow standard instructions.

Research & Related Other Project Information (Outreach and Networking Core) Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the "Are Vertebrate Animals Used?" question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Outreach and Networking Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Outreach and Networking Core)

Budget (Outreach and Networking Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Outreach and Networking Core) Specific Aims: State the specific aims for the Outreach and Networking Core and provide a rationale and description of how each aim enhances the operation of the Center.

Research Strategy:

Applicants must describe how the Center will conduct networking to recruit subject-matter experts such as drug developers, investors, regulatory experts, and intellectual property experts to serve as mentors and program faculty.

Applicants must describe how the Center will conduct outreach to recruit academic researchers, with an interest in transforming their research into new SUD pharmacotherapeutics, to participate in the program and explain how their outreach strategy will make individuals from different backgrounds and all career levels aware of the program. Applicants must provide detailed information on the infrastructure for soliciting, evaluating, and selecting the most promising applications, in consultation with NIDA staff.

Letters of Support:

Provide all letters of support that are appropriate for this project, including any letters of support from institutional officials and sources of non-federal resources.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide, with the following modification:

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Outreach and Networking Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - 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 How to Apply- Application Guide must be followed Drug Development Training and Education Core When preparing your application, use Component Type Training Core.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Drug Development Training and Education Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Drug Development Training and Education Core) Follow standard instructions.

Research & Related Other Project Information (Drug Development Training and Education Core) Human Subjects: Answer only the “Are Human Subjects Involved?” and “Is the Project Exempt from Federal regulations?” questions.

Vertebrate Animals: Answer only the "Are Vertebrate Animals Used?" question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Drug Development Training and Education Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Drug Development Training and Education Core)

Budget (Drug Development Training and Education Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Drug Development Training and Education Core) Specific Aims: State the specific aims for the Drug Development Training and Education Core and provide a rationale and description of how each aim enhances the operation of the Center.

Research Strategy: Applicants should provide a detailed discussion of how they plan to deliver the mentoring and training to the program participants.

Applicants must describe the development of a curriculum for a formal product development course for academic researchers interested in developing SUD pharmacotherapeutics. The course should emphasize the initial stages of product development, including idea generation and refinement, defining the TPP, defining and validating clinical needs, conducting user research, and considering regulatory and ethical aspects of product development. The curriculum may be done through different communication modes, including workshops, webinars, etc. For example, a 2- to 3- day in-person workshop could be included as part of the course, so program participants may connect and collaborate with other participants, their mentors, and additional experts in the Center’s network.

Applicants must describe the resources and expertise available to the Center to facilitate early product development education and mentoring services to program participants and demonstrate institutional support to create a sound educational environment for the participants.

Letters of Support:

Provide all letters of support that are appropriate for this project, including any letters of support from institutional officials and sources of non-federal resources.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide, with the following modification:

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Drug Development Training and Education Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.

Preclinical Study Support Core When preparing your application, use Component Type Preclin Study Core.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Preclinical Study Support Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Preclinical Study Support Core) Follow standard instructions.

Research & Related Other Project Information (Preclinical Study Support Core) Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the "Are Vertebrate Animals Used?" question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Preclinical Study Support Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Preclinical Study Support Core)

Budget (Preclinical Study Support Core) Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Preclinical Study Support Core) Specific Aims: State the specific aims for the Preclinical Study Support Core and provide a rationale and description of how each aim enhances the operation of the Center.

Research Strategy: Applicants should describe their expertise and readiness to issue and manage subawards to program participants to conduct early-stage feasibility studies.

Applicants must provide a plan for soliciting, evaluating, and nominating product development projects from the participants to distribute initial (seed) funding through subawards. Only a subset of participant proposals should be selected to receive a subaward for preclinical study. This plan should include a description for technical assistance to participants in preparing their product development proposals.