SBIR/STTR Funding

NIDA offers a broad range of funding opportunities that target all stages of biomedical product development (Ideation, Feasibility, and Product Development):

NIDA Entrepreneurial Development Funding Opportunities

To help researchers and entrepreneurs get their idea off the ground, NIDA offers several educational and training programs.

NIH SBIR and STTR Omnibus Solicitation

To help companies develop their innovative ideas, NIDA participated in the SBIR and STTR omnibus solicitation. The funding opportunity targets PI-initiated research (your own idea) that has the potential for technology commercialization and impact on public health.

• Notice of NIDA's Participation in PA-24-246 "PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)"
• Notice of NIDA'S Participation in PA-24-248 "PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)" 

Although NIDA considers a range of innovative technologies targeting substance use disorders, specific topic of interest for the NIDA SBIR/STTR programs include the following:

• Biomarker Development for SUDs
• SUD Drug Discovery and Development
• FDA-regulated Medical Therapeutic and Diagnostic Devices for SUD
• Technological Approaches to Decrease Stigma Associated with SUDs
• Digital Health Technologies to Address the Social Determinants of Health in context of
  SUDs
   

NIDA Targeted SBIR and STTR Funding Opportunities

These targeted SBIR/STTR grant solicitations are focused on specific research areas of interest to NIDA. These NOFOs can be RFAs (Requests for Applications); PAs, PARs, and PASs (different kinds of Program Announcements); and RFPs (Requests for Proposals).

Notices of Special Interest

NIDA also participates in Notices of Special Interest (NOSIs), which highlights specific topics or areas of interest. These NOSIs may be released by NIDA or other Institutes/Centers at NIH. 

• HIV Drug Resistance Assays and Actionable Data Dissemination Strategies (NOT-AI-21-056)
• BRAIN Initiative: Translation of Groundbreaking Technologies from Early-stage Development through Early Clinical Study via Blueprint MedTech (NOT-NS-22-052)
• HEAL Initiative: Clinical Translation of Diagnostic and Therapeutic Devices via Blueprint MedTech (NOT-NS-23-002)
• Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (NOT-OD-21-100)
• Priority Research Opportunities in Crisis Response Services (NOT-MH-22-110)
• Research on Strategies to Enhance Mental Health Interventions and Services within Employment and Job Training Settings (NOT-MH-21-230)
• Translation of BRAIN Initiative Technologies to the Marketplace (NOT-MH-21-125)
• Validation of Digital Health and Artificial Intelligence Tools for Improved Assessment in Epidemiological, Clinical, and Intervention Research (NOT-CA-22-037)

Archived Funding Opportunities

• Harnessing Artificial Intelligence and Polypharmacology to Discover Pharmacotherapeutics for Substance Use Disorders
  • SBIR R43/R44 (RFA-DA-25-054)
  • STTR R41/R42  (RFA-DA-25-053)
• Tools for Decentralized Clinical Trials for Substance Use Disorder
  • SBIR (RFA-DA-25-052)
  • STTR  (RFA-DA-25-051)
• Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment
  • SBIR R43/R44 (RFA-DA-24-018)
  • STTR R41/R42 (RFA-DA-24-017)   
• Leveraging Artificial Intelligence (AI) tools for Substance Use Disorders (SUD) drug discovery and development 
  • SBIR (RFA-DA-22-019)
  • STTR (RFA-DA-22-021)
• Mobile Health Solutions to rectify digital inequality in communities affected by drug addiction 
  • SBIR (RFA-DA-22-001)
• HEAL Initiative: America's Startups and Small Businesses Build Technologies to Stop the Opioid Crisis
  • SBIR (RFA-DA-19-019)
  • STTR (RFA-DA-19-020)
• Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders
  • SBIR (RFA-DA-21-031)
  • STTR (RFA-DA-21-032)
• Novel Approaches to Decrease Stigma of Substance Use Disorders in Order to Facilitate Prevention, Treatment, and Supporting During Recovery
  • SBIR (RFA-DA-21-015)
  • STTR (RFA-DA-21-016)
• Rapid Assessment of Drug Abuse: Smart City Tools 
  • SBIR (RFA-DA-20-020)
  • STTR (RFA-DA-20-021)
• Digital Health Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD)
  • SBIR (RFA-DA-20-017)
  • STTR (RFA-DA-20-018)
• Blockchain Technology to Improve SUD Care 
  • SBIR (RFA-DA-20-011)
  • STTR (RFA-DA-20-012)
• Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders
  • SBIR (RFA-DA-19-032)
  • STTR (RFA-DA-19-033)
• Mobile Technologies Extending Reach of Primary Care for Substance-Use-Disorders
  • SBIR (RFA-DA-19-021)
  • STTR (RFA-DA-19-022)
• Analytical Tools and Approaches for (Multidimensional) Scholarly Research Assessment and Decision Support in the Biomedical Enterprise 
  • SBIR ([RFA-DA-19-030)
  • STTR (RFA-DA-19-031)
• Development of a Device to Objectively Measure Pain
  • SBIR (RFA-DA-18-012)
  • STTR (RFA-DA-18-013)
• Nasal Delivery of CNS Therapeutics
  • SBIR (RFA-DA-18-006)
  • STTR (RFA-DA-18-007)
• Wearable to Track Recovery and Relapse Factors for People w/ Addiction
  • SBIR (RFA-DA-18-010)
• Extracellular Vesicle Tools, Technologies, and Products for Neuroscience Research
  • SBIR (RFA-DA-17-009)
  • STTR (RFA-DA-17-008)
• Improved Technologies and Ligands for Non-invasive Brain Imaging
  • SBIR (RFA-DA-17-011)
  • STTR (RFA-DA-17-010)
• Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research
  • SBIR (RFA-DA-17-017)
  • STTR (RFA-DA-17-016)
• Tools and Services for Designing Methodologically Rigorous Animal Studies
  • SBIR (RFA-DA-16-003)
  • STTR (RFA-DA-16-002)
• Tools for Monitoring and Manipulating Modified RNAs in the Nervous System
  • SBIR (RFA-DA-15-001)
  • STTR (RFA-DA-15-002)
• Abuse-Resistant and Abuse-Deterrent Formulations and Devices to Avoid the Abuse, Misuse and Diversion of Prescription Opioids by Patients (SBIR)
  • SBIR (RFA-DA-14-013)
• Pharmacological Development of Treatment Agents and Formulations for Tobacco Dependence
  • STTR (RFA-DA-11-004)

FAQs for Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (RFA-25-056)

Thank you for your interest in this new funding opportunity RFA-DA-25-056, “Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics.” If you have any questions after reviewing the FAQ, please contact Dr. Tam Nguyen (tam.nguyen@nih.gov) and Dr. Sara Lioi (sara.lioi@nih.gov) who are available to assist you and can arrange a phone call or meeting at your convenience.

Frequently Asked Questions

Questions on the Budget:

Q: Can you walk through the sample budget in the NOFO in more detail?
A: The budget table in the NOFO is a sample. Applicants should propose their specific budget allocations for Overall (Administrative), Outreach and Networking, Drug Development Training and Education, and Subproject Management. The total direct costs must not exceed $1.9 million per year, with a direct cost limit of $1.4 million for Subproject Management. 

In the sample budget provided in the NOFO, the figures total $1.9 million, assuming a maximum of $1.4 million for Subproject Management. However, it is not required to allocate $1.4 million for subawards. Applicants can propose different allocations among the Overall, Outreach and Networking, Drug Development Training and Education, and Subproject Management components. The total budget for all components must not exceed $1.9 million in direct costs, and the budget for Subproject Management must not exceed $1.4 million in direct costs. Different budget values can be proposed for any of the components, as long as these limits are not exceeded.

Q: The maximum budget is $1.9 million in direct costs per year with a maximum of 5 years. How is the center reviewed for renewals?
A: The Center will be evaluated for renewal in an internal NIDA process based on performance in executing the components in the NOFO.

Q: I want to better understand how the budget for this opportunity works. Is the total budget for the Center $3M (including $1.9M for direct costs), or $1.9M? 
A: For this NOFO, your budget should be no more than $1.9 million per year in direct costs; this doesn’t include subaward F&A. Your budget should be within that direct costs level +  apply your institution’s current F&A rate.

Q: The direct cost limit is $1.9 million, and the solicitation states that NIDA intends for a $3M total award. If an institution wants to propose $1.9 million in direct costs, and the direct costs level + the institution’s current F&A rate is more than $3M in total budget. Would the application in this scenario that has a total budget over $3M be eligible or responsive? 
A: Yes, this application would be responsive.

Q: Are the individual projects (subprojects) up to $200,000 per year, or per project? And can a project span multiple years?
A: Each subproject is limited to a maximum of $200,000 in direct costs per project. The budgets for subprojects will vary depending on the specific studies being conducted, and subaward direct costs can be significantly less than $200,000. While subprojects can span multiple years, our goal is to complete each project within a year. Ideally, we aim to have new projects starting and finishing each year.

Non-Budget Questions:

Q: The NOFO mentions having a track record of successfully transitioning biomedical products. What is the definition of “successfully transitioning”? For example, there are only a handful of medications that have FDA approval for the treatment of substance use disorders, so is that what is meant by “successfully transitioning”?
A: Successfully transitioning products includes all events that occur in the process of bringing products to market. The products don’t necessarily have to be FDA approved, but if there is expertise in taking products out of the lab and working towards FDA approval, that would be sufficient. In addition, everyone on the team doesn’t have to have expertise in transitioning products, as long as that expertise is well-represented in the application. The expertise in transitioning products might not necessarily be in SUD. Expertise in CNS diseases would be helpful.

Q: I read through the RFA, and applicants are instructed to describe how to set up a center that has the listed functionalities and recruit people to it. Can this center itself have components where it proposes its own projects, or is that expressly forbidden?
A: The participants can be members of your institute. They must go through the same process as other potential participants- they will be evaluated to make sure they're committed, motivated, and have an interesting project. The process of how participants will be chosen is required to be described in the application.

Q: Regarding the subaward portion of the center, are you just looking for a description of how the administration of the subawards would be coordinated by the center and the hours required, or do you need a description of what type of project would be a subaward as well? 
A: In the application, it will be important to demonstrate how your institution will manage the subaward and describe any previous experience your institution has in managing subawards like these. As a demonstration of your experience, for example, you could write up a test case where you show that you know how to successfully manage subawards.

Q: There are only so many ways to deliver the training, for example, a formal course, holding seminars, online content, etc. Is there any guidance in terms of what kind of method is preferred for the course? 
A: It was written to be open so that it could fit the applicant institute’s best method of practice. The only thing noted as a requirement is a 2-to-3-day in-person portion of the course so the participants can meet their mentors and interact with the mentors and other participants.

Q: Is it expected or required that the applicant has received previous funding from NIDA?
A: It is not expected or required that the applicants have received NIDA funding in the past. All that is required is that the PI should have demonstrated expertise and ability to establish and run the Center and that the institution has the assets needed to run the Center.

Q: Will NIDA select the final subprojects (subawards)?
A: The Center will select the final subprojects in collaboration with NIDA.

Q: Is NIDA’s vision for the Center to be based at a single institution, or to be a collaboration among multiple institutions in the same geographic area?
A: NIDA does not have a preference for either scenario. It all depends on the institutions that are collaborating and what strengths they bring to one another that may be greater or equal to the strengths of a single institution.

Q: If the applicant is a foreign institution, will the in-person requirement for participants still apply, and how would it affect the budget?
A: The in-person requirement would apply.  The participants in the training course will be US-based researchers, so ideally, the in-person portion of the course would be in the US even though the organization applying is a foreign institution. Holding the in-person portion of the training course in the US would likely be less costly in terms of the budget.

Q: Does the in-person component need to be conducted in the location of the institution, whether the institution is foreign or not?
A: It's up to the applicant to propose the location of the in-person training component. NIDA has no requirement that the in-person component be held at the institution(s) involved in the application.

Q: You said there would be only a single award made. Can you give more information on the long-term plan? What do you hope to accomplish with this program so that you grow it? And are you planning to keep building it to more awards in the next 5-10 years?
A: Yes, this funding opportunity is a single award for a single center. The first-year success is critical, and there is the potential for 5 years of funding in total. We should have a new cohort of participants every year during the 5 year period. Every year, we hope to build up this ecosystem of new investigators and new products in the pipeline. We have aspirations, but we can't commit to anything that's not in writing at this time. We hope to grow the program to support product development as future resources allow,  and the ongoing success of this program will be assessed to justify further initiatives.

Q: Is this center intended to be a national, regional, or local program?
A: Since NIDA is awarding one center at this time, the Center is a national program and it should have a national reach. NIDA hopes that researchers from all states would be interested in applying to participate.

Q: Will the Center be expected to develop its own research projects? 
A: The Center would not develop its own research projects. The Center is required to actively engage the research community to recruit program participants across the US. The research projects will come from the program participants. The projects will involve SUD indications (i.e. opioid use disorder, tobacco use disorder). Projects solely focused on alcohol use disorder would not be responsive.

Q: Does a researcher need to participate in the training in order to receive seed funding?
A: Yes, the researcher is required to complete the training program and to develop a concept proposal before being considered by the Center for seed funding.

Q: Would program applicants working to develop digital therapeutics be responsive to this NOFO?
A: This NOFO is for the development of SUD pharmacotherapeutics, and projects involving only digital therapeutics would not be responsive.

Questions on Additional Information:

Q: Will the recording of the webinar presentation be made available to everyone?
A: Yes, we will be making the presentation slides available to everyone, and we are planning to post the recording on the NIDA website as well. Please contact Dr. Tam Nguyen (tam.nguyen@nih.gov) and Sara Lioi (sara.lioi@nih.gov). UPDATE: View the webinar.

Q: Is it okay for potential applicants to contact you? 
A: Absolutely. Please contact us any time between now and the due date of November 13, 2024. Here is our contact info: Dr. Tam Nguyen (tam.nguyen@nih.gov) and Sara Lioi (sara.lioi@nih.gov)

Webinar

View the webinar - Establishing a Center for the Advancement of Substance Use Disorder Pharmacotherapeutics.