Developing Medical Devices to Treat Pain - Frequently Asked Questions

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Program staff will be at a number of upcoming meetings:

• International Society of Autonomic Neuromodulation (Jul 25-27, 2019 in Los Angeles, CA)

Cost sharing is currently required in the U18, UG3/UH3, and U44 when the primary applicant is a for-profit entity. Not for profit universities do not need to provide cost-sharing. Further, cost sharing is not required when a for-profit entity is a sub-awardee. Applicants should use their best effort to address the cost sharing requirement, but should not let the requirement deter them from applying.

A notice was recently released rescinding the cost-sharing requirement for applications submitted to the SBIR and STTR omnibus opportunities.  Please see NOT-NS-19-014 for additional information.

For all five funding opportunities - budgets should reflect the actual needs of the project. Effort should wax or wane to reflect the tasks proposed each year. Clear and strong justifications should be provided for all funds requested. Note additional information below, and provided in the announcements:

• U01: Budgets should rarely exceed $500,000 direct costs per year.
• U18: Budgets should rarely exceed $500,000 direct costs per year.
• U44: (SBIR Fast-Track and straight to Phase II): Budgets should rarely exceed $1M in total costs per year in Phase I and $1.5M in total costs per year in Phase II.

Yes. Including a specific aims page is also encouraged.

• RFA-RM-19-001 will be reviewed in a Special Emphasis Panel (SEP) run by Robert Elliott in the Center for Scientific Review (CSR). This is the same Scientific Review Officer (SRO) who runs the Bioengineering of Neuroscience, Vision and Low Vision Technologies (BNVT) study section.
• Applications will be reviewed between June and July of 2019 and will go to the Advisory Council Round in October of 2019.
• RFA-EB-18-003, RFA-NS-19-016, RFA-NS-19-018, and RFA-NS-18-017 will be reviewed by a special emphasis panel through the National Institute of Neurological Disorders and Stroke (NINDS).
  • The first round of applications for the Translational and Clinical Devices to Treat Pain FOAs (RFA-NS-19-016, RFA-NS-19-018 and RFA-NS-18-017) are due January 9, 2019 and  will be reviewed in March 2019. They will go to the Advisory Council Round in May 2019.
  • Applications submitted to the March 22 due date of all four FOAs will be reviewed in June 2019 and will go to the Advisory Council Round in August 2019.

Please clarify the U18 timeline. The RFA says it's due March 22, scientific merit review April, Council May, and Earliest start July.

The first round of applications for the U18 are due on March 22, 2019. They will be reviewed in June 2019 and will go to the Advisory Council Round in August 2019. 

Parts of funding awards are publicly available via NIH Reporter. 

• In addition, the Project Outcomes Section of all Interim and Final Research Performance Progress Report (RPPR) Submitted on or After October 1, 2017 will be made Available via the NIH RePORTER (see NOT-OD-18-103 for more information).

The first round of applications for the U18 are due on March 22, 2019. They will be reviewed in June 2019 and will go to the Advisory Council Round in August 2019.

Scientific contacts are listed at the end of each of the funding opportunities. You may also use the list below:

• U01: Gene Civillico and Michael Oshinsky
• U18: Michael Wolfson
• UG3/UH3: Nick Langhals and Kari Ashmont
• UH3: Nick Langhals and Kari Ashmont
• U44 (SBIR Fast-Track and straight to Phase II): Nick Langhals and Kari Ashmont

If you are not sure which funding opportunity is the best fit for your project, we suggest copying everyone listed above.

Using the Public Private Partnership Programs through the SPARC Program and/or the BRAIN Initiative is not required. The programs are set up to facilitate collaboration between academic investigators and industry partners and offer pre-negotiated research agreements intended to lower the administrative burden typically associated with establishing such relationships. Participation and use of the resources are at the discretion of the investigator and the intended industry partner.

Program staff will review applications to identify those relevant to the HEAL Initiative. A reference to the HEAL Initiative is not required.

Yes.

• RFA-NS-19-016, RFA-NS-19-018, and RFA-NS-18-017 do not allow direct to foreign applications, though subawards might be considered. Note that foreign collaborations need to be special opportunities and clearly justified.

Early stage investigators are welcome to apply, but there will not be special consideration given to those with ESI status. These award mechanisms (U01, U18, UG3/UH3, UH3, or U44) are all considered R01 equivalents. Applicants will therefore lose ESI status if they are a principal investigator of an application that is awarded. 

Yes.

Yes.

Yes, this would be considered a “new target”, provided the cellular basis of any existing mechanisms of action are not well-understood.

Small businesses are welcome to apply for either the U44 or the U18. The decision between the two funding opportunities would depend on the amount of development needed. If the project will only focus on device development, the U18 or omnibus SBIR opportunities would likely be applicable. If the development work will be concluded within two years, there is a clear path to FDA and IRB approval, and a full clinical protocol can be included in the application, the U44 Fast-Track may be a good option. For additional guidance, please send a specific aims page to Michael Wolfson, Nick Langhals and Kari Ashmont.

Yes, please see the document, which one could consider to be an extremely abridged version of the FOA. If there is any inconsistency or you require clarification due to lack of details, please refer to the corresponding section of the FOA.

The targeted population size that a device addresses is not a factor that will impact funding considerations from a program perspective.

The use of indirect measures is not excluded.

Applicants should describe the current understanding of the mechanism of pain as it relates to the justification and rationale for the use of a device-based treatment approach.

If the in vitro studies are a necessary part of the development process, yes; they would be allowed in RFA-EB-18-003, RFA-NS-19-016 (UG3 Phase), and RFA-NS-18-017 (U44 Phase I).

• This would depend on the specifics of the study design. Sending a specific aims page and having a conversation with the scientific contact for the opportunity you are interested in is the best way to be certain.
• The work may also be responsive to other opportunities offered through the NIH HEAL Initiative. A complete list of funding HEAL Initiative opportunities is here. 
• If the project involves the central nervous system you may also consider: RFA-NS-18-018 - BRAIN Initiative: Biology and Biophysics of Neural Stimulation (R01 Clinical Trial Optional)

The most appropriate funding opportunity would depend on the amount of development needed. For additional guidance, please send a specific aims page to Nick Langhals and Kari Ashmont

The most appropriate funding opportunity would depend on what was being proposed in the application. Depending on the maturity of the study, either the UH3 or a clinical trial network may be good options. For additional guidance, please send a specific aims page to Nick Langhals and Kari Ashmont.

The goal of these funding opportunities is to support non-addictive, device-based pain treatments. Projects involving the expansion of spinal cord stimulation technology are welcome to apply, but preference will not be given to any one type of technology or device.

• RFA-RM-19-001 - HEAL Initiative: Stimulating Peripheral Activity to Relieve Conditions (SPARC): Anatomical and Functional Mapping of Pain-Related Visceral Organ Neural Circuitry (U01 Clinical Trial Optional)
• RFA-EB-18-003 - HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
• RFA-NS-19-016 - HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)
• RFA-NS-19-018 - HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
• RFA-NS-18-017 - HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional)

Additional funding opportunities associated with the HEAL Initiatives are available here. 

The NIH will not facilitate contact or act as intermediary between an investigator and the FDA. Investigators should contact the FDA directly. The FDA offers multiple guidance documents regarding types of meetings they offer and how to initiate contact. The Division of Industry and Consumer Education (DICE) is a great place to start using DICE@fda.hhs.gov.

If the project is proposing to obtain an Investigational Device Exemption (IDE) or a risk-determination, and includes a clinical trial, interactions with the FDA should be accounted for in the project timeline.

Yes.