National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
U54 Specialized Center- Cooperative Agreements
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.
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.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 30, 2026 | Not Applicable | Not Applicable | March 2027 | May 2027 | 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).
Not Applicable
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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:
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.
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.
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.
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.
NIDA intends to commit $3 million to fund one award in FY 2027.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
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.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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.
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.
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.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
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:
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.
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.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 12 | Required | 1 | 1 |
| Administrative Core | Admin Core | 6 | Required | 1 | 1 |
| Outreach and Networking Core | Outreach Core | 6 | Required | 1 | 1 |
| Drug Development Training and Education Core | Training Core | 6 | Required | 1 | 1 |
| Preclinical Study Support Core | Preclin Study Core | 6 | Required | 1 | 1 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
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.
Complete entire form.
Follow standard instructions.
Follow standard instructions.
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.
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.
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.
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.
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.
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:
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:
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. This should include a description of how the Center will collaborate with NIDA to reach an agreement on the selection of research projects to be funded. Applicants should describe how the selected preclinical study awardees will receive technical assistance to refine their experimental protocol. Applicants must describe the process to establish subawards.
Applicants must include a section describing a project management oversight process to enable early-stage product development experiments of the program participants, including technical advice to the subawardees. The project management support must include ensuring compliance with all applicable NIH guidelines and policies and monitoring the progress of the experiments. The program management must include a plan to monitor the progress of the preclinical studies.
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 (Preclinical Study Support 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
Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the How to Apply - Application Guide.
See Part 2. 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
Part I. 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) using ASSIST or other electronic submission systems. 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 How to Apply- Application Guide.
This initiative is not subject to intergovernmental review.
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.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
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) and component Project Leads 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.
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 How to Apply - 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.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to 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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Cores collectively to educate addiction researchers on the product development process for SUD pharmacotherapeutics and support networking and additional experiments to further the participants' ideas, in consideration of the following review criteria. Criterion scores will not be provided for the Cores.
Review Criteria -Cores
Reviewers will consider each of the review criteria below in the determination of scientific merit.
Review Criteria - Administrative Core
Is an appropriate description provided outlining the Center’s organizational structure, including any strategies for overseeing, managing, and coordinating the entire range of proposed Center activities?
To what extent does the proposed Center leadership (including the PD(s)/PI(s)) demonstrate the necessary operational, scientific, and business expertise to run a Center that provides training to academic SUD pharmacotherapeutic researchers and manages preclinical studies via subawards including ensuring compliances with NIH guidelines and policies?
Review Criteria - Outreach and Networking Core
To what extent are the proposed activities likely to successfully establish or enhance sustainable partnerships with subject matter experts and program participants as part of the Center's goals?
To what extent are the outreach and networking strategies designed to promote the Center's activities reasonable and likely to attract substance use, addiction, and other researchers interested in developing pharmacotherapeutics for SUD?
Review Criteria - Drug Development Training and Education Core
How well does the Center specially tailor the program to SUD pharmacotherapeutic research?
To what extent is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants?
Review Criteria - Preclinical Study Support Core
How well does the applicant demonstrate the ability to select promising concepts for further support, and to issue and manage sub-awards?
Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by CSR, 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 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 National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.
After the peer review of the application is completed, the PD/PI will be able to access their 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.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
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.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations 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.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.”
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
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 PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
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 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.
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.
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 Section 8.6 Closeout. 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.
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.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Office of Translational Initiatives and Program Innovations
National Institute on Drug Abuse (NIDA)
Email: nidaotipi_nofo@mail.nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
Chief Grants Management Officer
National Institute on Drug Abuse (NIDA)
Email: nidagmbemail@nida.nih.gov
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.