Developing Medical Devices to Treat Pain - Frequently Asked Questions

 

NIBIB’s role in the NIH HEAL Initiative

NIBIB is playing a major role in the National Institutes of Health (NIH) HEAL (Helping to End Addiction Long-termSM) Initiative, a trans-agency effort focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. Launched in April 2018 with funding from Congress, the HEAL Initiative brings new hope for people, families, and communities affected by the national opioid public health crisis.

Learn more about the NIH HEAL InitiativeSM.

General HEAL Info

Budget Info

Grant Process

Mechanism Info

Project Scope

Application Details

General

Where are the slides from the Webinar posted?

Click here to download webinar slides.

Where are the full funding opportunity announcements found?

  • 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.  

Can we email a letter of intent even though the 30 days prior to submission of grant application is passed due?
Yes. Including a specific aims page is also encouraged.

How will these applications will be reviewed (study section, timeline, etc)?

  • 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. 

If a grant is approved, will the details be publicly available?
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).

Where should we send the specific aims pages for feedback?
Scientific contacts are listed at the end of each of the funding opportunities. You may also use the list below:

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

Can the NIH facilitate contact with the U.S. Food and Drug Administration (FDA) for investigators?
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.
  
Does the FDA path need to be laid out in the application?
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.

Can a draft specific aims page be submitted before discussions with the FDA?
Yes.

Is improving devices that are already in clinical use in scope RFA-NS-19-016, RFA-NS-19-018, and RFA-NS-18-017?
Yes.

Would a new application/use of a standard DBS device be in scope RFA-NS-19-016, RFA-NS-19-018, and RFA-NS-18-017?
Yes.

Will in vitro preclinical studies be considered as part of the technology development if they address questions that are key to the development plan?
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).

Would a project studying the mechanism of action of an existing pain device be in scope?

For the U18 mechanism, is public-private partnership necessary/encouraged? Is it preferred to have a letter of support from a neuromodulation company?
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.

Which funding opportunity is most appropriate for an existing device/technology with demonstrated effectiveness in human, but that needs additional development work to make it applicable to a different pain condition/population?
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

Which funding opportunity would be most appropriate if we already have proof of concept in humans?
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.

Will the technology development opportunity favor expansions of spinal cord stimulation technology?
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.

For RFA-EB-18-003, would development of new technology to engage an already known target with greater specificity be in scope?
Yes, this would be considered a “new target”, provided the cellular basis of any existing mechanisms of action are not well-understood.

Should the U44 or U18 be used for a small business developing a device?
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.

Is cost sharing a requirement?
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.

Is cost-sharing required for an application that is responsive to HEAL, but is submitted to the omnibus SBIR solicitation?
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.

Should we/how can we flag an SBIR or STTR submitted via the omnibus solicitation as intended for the HEAL Initiative?
Program staff will review applications to identify those relevant to the HEAL Initiative. A reference to the HEAL Initiative is not required.

Will any/all of you be at upcoming meetings where you would be available to meet in person?
Program staff will be at a number of upcoming meetings:

How detailed do descriptions of pain mechanism need to be?
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.

Can a US company apply with a foreign academic institute as a collaborator?
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.

I am a junior investigator and still have my “early stage investigator” (ESI) status. Will I lose my ESI status if I get one of these grants?
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. 

How will the overall budget of a project impact the consideration of it being selected for funding?
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.

How impactful is the population size that a device addresses when a grant is considered?
The targeted population size that a device addresses is not a factor that will impact funding considerations from a program perspective.

Can we use indirect measures of pain (e.g. pro-inflammatory molecules) as opposed to direct biomarkers and/or behavioral markers for pain?
The use of indirect measures is not excluded.
 
Can you highlight some of the unique features of the U18 FOA?
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.