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Questions & Answers from December 12th Webinar

Revised December 2019

Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research - Q&A from Webinar

  1. Is the opioid induced respiratory depression within a scope of this RFA?
    Drug target validation for opioid induced respiratory depression is within the scope of this RFA.
  2. Are models limited to those in the RFA?
    The RFA says that the proposed studies could include, but are not limited to, the models listed in the RFA. If your model is related to drug target validation, please contact us to know whether the proposed drug target is responsive to the RFA.
  3. Can the tissue model be cardiac or any other tissue for drug target validation?
    Models that are essential in validating the proposed drug targets in any tissue are allowed. Please contact us if you would like to discuss further.
  4. Would a target (and drug formulation) that prevents opioid analgesic-associated development of opioid use disorder (OUD) be responsive to this RFA?
    The question is not clear to provide an answer. Please contact us.
  5. Can we have international collaborators?
    Yes.
  6. Since we are a small business and depend on working with other organization including CROs to get the work done, does this allow to subcontract all or part of the project?
    Yes, for this RFA small business can subcontract part of the project.
  7. Is there a list a list of product development experts available?
    We do not have a list of product development experts.
  8. Are we required to present preliminary results for the proposal?
    Preliminary results to support your proposal are not required but encouraged.
  9. Can a drug that combines two existing generic medications apply?
    Yes. A proposed drug could be a combination of two existing generic medications.
  10. Who would hold the IP of any discovered molecules?
    The Principal Investigator (PI)'s institutions retain their assignment of IP rights and gain assignment of IP for drug target candidates or drug candidates developed through this FOA. It is expected that the PI institutions will take responsibility for patent filings, maintenance and licensing efforts toward commercialization.
  11. I am at a small business trying to develop a novel treatment for neuropathic pain. This would be a non-opioid treatment. Is this type of project appropriate for this RFA?
    Developing a novel treatment for neuropathic pain is not responsive to this RFA. We suggest to please contact NINDS for all pain related medication development projects.
  12. What is the format of the letter of intent and what specifically must be included in the letter of intent? The letter of intent should have no summary of the proposal? Is there page limit?
    Prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity, Name(s), address(es), and telephone number(s) of the PD(s)/PI(s), Names of other key personnel, Participating institution(s), and Number and title of this funding opportunity. The letter of intent should be sent to: NIDALetterofintent@mail.nih.gov
  13. Is this RFA only intended to support pre-clinical research?
    Yes, this RFA only supports pre-clinical work.
  14. Is there a list of biological targets that are of clear interest to NIDA? Or, is the RFA looking for ideas for new targets?
    This RFA is looking for ideas for new targets.
  15. Much of the emphasis was on drug targets, but the scope of eligible studies appeared to include many other opportunities for exploration. I want to confirm that projects not involving drug targets would still be eligible for this grant. Is this so?
    The focus of the RFA is drug target validation and projects not related to drug targets are not responsive to this RFA.
  16. How many pages you expect for this application considering it is a one-year contract?
    The maximum allowed limit is 12 pages. The PI can determine the number of pages (not exceeding the limit of 12) needed to explain the proposal.
  17. We are a small business entity. For SBIR applications the PI must be >51% employee of the small business entity. Is this applicable for PIs in this U18 FOA?
    No. This restriction does not apply to this RFA, however the PI must have an official relationship with the applicant organization and this should be made clear in the application.
  18. Is the discovery of less addictive opioids by derivatization of scaffolds and initial test of receptor binding of interest for this RFA?
    If the application is for substance use disorder, then this is responsive to the RFA. If it is for pain treatments, then it is not responsive.
  19. For biological target testing, do we need to identify small molecule or another modulator for the target? Does this mechanism support testing of the target by biological means such as knock-out and transfection?
    For biological testing of a target, small molecule, or another modulator for that target needs to be identified. Only testing of the target by biological means such as knock-out and transfection would not be directly responsive to this RFA.
  20. Can I propose to validate a drug target which was never studied in drug addiction if I have supporting animal data?
    Yes. Validating a drug target which was never studied in drug addiction would be responsive to this RFA.
  21. Are techniques such as machine learning, etc of interest for this RFA? Will you provide data or point to data that can be used for evaluation and testing?
    NIDA will not be providing data or point to data that can be used for evaluation and testing.
  22. Will there be another due date for this?
    No. There is only one due date. RFA expiration date is February 14th, 2020.
  23. If a foreign collaborator is involved, but not requesting funding, does the same international institution registration requirement apply?
    Yes. The same international institution registration requirement is needed even if they are not requesting funding.
  24. If PI's US organization contracts foreign institution for experimental work, should the foreign institution get the DUNS?
    Yes. Still foreign institution will need to obtain DUNS.
  25. Are multi-PI applications allowed for this RFA?
    Yes. Multi-PI applications are allowed for this RFA.
  26. If one proposes to develop an in vitro assay that reliably expresses the molecular targets of a substance of abuse, must rigorous target validation experiments also be conducted as part of the in vitro assay development? Thanks.
    Conducting rigorous target validation experiments in the development of in vitro assay should be the standard practice. Please contact us directly to discuss this further.
  27. My potential contributions to the RFA project lie in area of "Development and validation of in vitro and in vivo assays" to identify target molecules. Yet the RFA seems to require fixation on a single molecular target. Is this correct or would an assay designed to identify a well-defined and potentially small class of molecular targets also be responsive?
    Developing and validating a screening in vitro and in vivo assay development would not be directly responsive to this RFA.
  28. I noticed that proposals for medical device development are not eligible for this grant. However, would new drug concept proposals that happen to involve an already developed and FDA-approved medical device be eligible for this grant?
    At this point RFA does not support devices. Please contact us if you are interested in discussing other current opportunities available for Medical Devices development.
  29. Can an international institute collaborate with an US institution?
    Yes. An international institute can collaborate with an US institution.
  30. Are Genetic editors such as CRISPR based tools within the scope of this RFA?
    Yes. If they are used to modulate the target of the proposed drug. Please contact us to discuss this further.
  31. One question is whether this NIDA program will provide specific substances to PI/PDs to test using their model systems.
    No. NIDA will not provide specific substances to PI/PDs to test.
  32. The presentation states that "this program is to "validate/de-validate 50 targets" -- does it mean you will select "target" to be studied, and you will identify the investigator to perform the study? in other words, if 5 investigators choose to study a particular target, one can be funded?
    The same target could be studied by multiple investigators.
  33. Would development of compounds derived from a validated SUD drug but plagued with side-effects (cardiovascular hERG liabilities) be responsive?
    If the proposed studies are aiming to improve compounds without those side effects, it would be responsive. Please contact us to discuss your proposal.

More information available at - Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research

This page was last updated December 2019

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