Opportunity Information: Apply for RFA MH 16 220
Apply for RFA MH 16 220
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Assays to Address Translational Gaps in Treatment Development (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
- This funding opportunity was created on Jan 12, 2015 and posted on Jan 12, 2015.
- Applicants must submit their applications by Apr 3, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Special district governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Small businesses Private institutions of higher education Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) 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.
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Opportunity Summary:
The NIH grant opportunity "Novel Assays to Address Translational Gaps in Treatment Development (UH2/UH3)" is a cooperative agreement designed to tackle a persistent problem in mental health therapeutics: promising findings in animal studies often fail to carry over into humans during clinical testing. The central aim is to identify neurophysiological processes that are disrupted within or across mental disorders, then develop practical, reliable measures of those processes that can be assessed in both preclinical species and humans. By creating assay tools that work similarly across species, the program is meant to strengthen the link between early-stage discovery and later-stage clinical evaluation, so that treatment candidates can be selected and advanced with clearer evidence of target engagement and meaningful brain-level effects.
A major emphasis of the initiative is assay development that is genuinely translational rather than merely parallel. Applicants are expected to optimize and evaluate brain-based measures that can serve as functional readouts of neural circuitry or physiological mechanisms relevant to mental disorders, with the explicit requirement that these measures be deployable in animals and in humans. The opportunity is also structured to produce informative negative results: if an assay behaves differently in humans than it does in preclinical species, the resulting data should help establish boundaries on how far animal findings can reasonably be extrapolated. In practical terms, this is intended to reduce speculative leaps in the drug and device development pipeline by making it clearer which preclinical readouts are truly predictive of human neurophysiology and which are not.
The FOA is organized around building a "suite" of assays that connect target engagement to functional brain effects. That means projects are expected to do more than show that a compound, device, or manipulation can change behavior; they should demonstrate that a specific biological target is engaged and that this engagement produces measurable effects on brain function using assays that can be run across species. The program supports the development, refinement, and testing of these assays in preclinical models and in healthy human participants, with assay performance evaluated under carefully selected chemical, physiological, or behavioral manipulations. This approach allows investigators to stress-test assay sensitivity, reliability, and interpretability, and to map out how the measures respond under conditions that are relevant to treatment mechanisms.
The initiative strongly encourages team science and is framed around partnerships between basic neuroscientists and translational researchers who are committed to turning physiological measurements into actionable tools for therapeutic development. The expected outcome is a set of better-validated, better-aligned neurophysiological assays that can be used to screen and prioritize treatment candidates before costly clinical trials, improving efficiency and increasing the likelihood that clinical testing focuses on interventions with stronger mechanistic justification. Ultimately, the goal is to speed the arrival of more effective treatments for mental disorders by repairing a weak link in the development chain: the mismatch between preclinical screening readouts and the measures used to evaluate candidate therapies in humans.
From an administrative standpoint, this funding opportunity was issued by the National Institutes of Health under Funding Opportunity Number RFA-MH-16-220. It uses the UH2/UH3 cooperative agreement mechanism, which typically reflects a staged, milestone-driven structure with substantial NIH program involvement, suitable for projects that require coordinated development and evaluation phases. The activity category is Health, listed under CFDA 93.242 (Mental Health Research Grants). The program did not require cost sharing or matching, and the estimated total funding amount listed for the opportunity was $1,500,000. The posting and creation date were January 12, 2015, with an original and current closing date of April 3, 2015, and an archive date of May 4, 2015.
Eligibility was broad and included many types of organizations, reflecting the program's interest in interdisciplinary collaboration and wide participation. Eligible applicants included public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, for-profit organizations (other than small businesses), and multiple levels of government (state, county, city/township, special district, and certain tribal entities). The FOA also explicitly allowed applications from non-U.S. entities and foreign institutions, non-domestic components of U.S. organizations, and foreign components as defined under NIH policy. Additional eligible categories included minority-serving institutions (such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities), as well as faith-based or community-based organizations, U.S. territories or possessions, and regional organizations. The full announcement was linked through the NIH grants guide at the provided URL, with technical assistance contacts routed through the NIH Office of Extramural Research webmaster.
Frequently Asked Questions (FAQs)
1. What is the NIH funding opportunity called?
The opportunity is titled "Novel Assays to Address Translational Gaps in Treatment Development (UH2/UH3)."
2. What problem is this grant trying to solve?
It targets a persistent translational gap in mental health therapeutics: promising findings in animal studies often do not carry over into humans during clinical testing. The program aims to improve how preclinical evidence connects to human neurophysiology so treatment candidates can be advanced with clearer mechanistic support.
3. What is the central scientific aim of the program?
The central aim is to identify neurophysiological processes that are disrupted within or across mental disorders and to develop practical, reliable measures (assays) of those processes that can be assessed in both preclinical species and humans.
4. What does "genuinely translational" assay development mean in this FOA?
It means developing brain-based measures that function similarly across species (animals and humans), not just running separate but loosely related measures in each. The explicit requirement is that the measures be deployable in both animals and humans.
5. What kinds of measures or readouts does the FOA emphasize?
The FOA emphasizes brain-based neurophysiological measures that can serve as functional readouts of neural circuitry or physiological mechanisms relevant to mental disorders, and that can be run across species.
6. Is the goal to measure behavior changes?
Projects are expected to do more than show that a compound, device, or manipulation changes behavior. They should demonstrate that a specific biological target is engaged and that this engagement produces measurable effects on brain function using cross-species assays.
7. What does the FOA mean by building a "suite" of assays?
Projects are organized around developing a set of assays that connect target engagement to functional brain effects, with assays that can be applied in preclinical models and in humans. The idea is to create aligned tools that strengthen decision-making across the development pipeline.
8. Does the program support work in humans?
Yes. The program supports development, refinement, and testing of assays in preclinical models and in healthy human participants.
9. Are patient populations required for the human component?
Based on the provided description, the FOA specifically mentions healthy human participants for assay testing; it does not state that patient populations are required.
10. How is assay performance expected to be evaluated?
Assay performance is expected to be evaluated under carefully selected chemical, physiological, or behavioral manipulations. This is intended to stress-test assay sensitivity, reliability, and interpretability, and to map how measures respond under conditions relevant to treatment mechanisms.
11. Why does the FOA mention the value of negative results?
The opportunity is structured to produce informative negative results. If an assay behaves differently in humans than it does in preclinical species, those data help establish boundaries on how far animal findings can be extrapolated to humans, reducing speculative leaps in development.
12. How does this FOA aim to improve treatment development?
By producing better-validated and better-aligned neurophysiological assays that can screen and prioritize treatment candidates before costly clinical trials, helping ensure that clinical testing focuses on interventions with stronger mechanistic justification.
13. Does the FOA encourage collaboration or team science?
Yes. It strongly encourages team science and is framed around partnerships between basic neuroscientists and translational researchers focused on turning physiological measurements into actionable tools for therapeutic development.
14. What NIH mechanism is used for this opportunity?
It uses the UH2/UH3 cooperative agreement mechanism.
15. What does it mean that this is a cooperative agreement (UH2/UH3)?
The provided information describes it as typically staged and milestone-driven, with substantial NIH program involvement, and suited for projects requiring coordinated development and evaluation phases.
16. What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-MH-16-220.
17. Which NIH area or category is associated with this opportunity?
The activity category is Health, listed under CFDA 93.242 (Mental Health Research Grants).
18. What was the estimated total funding amount for the opportunity?
The estimated total funding amount listed was $1,500,000.
19. Was cost sharing or matching required?
No. The program did not require cost sharing or matching.
20. When was this opportunity posted?
The posting and creation date was January 12, 2015.
21. What was the closing date for applications?
The original and current closing date was April 3, 2015.
22. When was the opportunity archived?
The archive date was May 4, 2015.
23. Who was eligible to apply?
Eligibility was broad and included public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); small businesses; for-profit organizations (other than small businesses); and multiple levels of government (state, county, city/township, special district, and certain tribal entities).
24. Are non-U.S. organizations eligible?
Yes. The FOA explicitly allowed applications from non-U.S. entities and foreign institutions, non-domestic components of U.S. organizations, and foreign components as defined under NIH policy.
25. Are minority-serving institutions specifically included in eligibility?
Yes. The eligible categories explicitly included minority-serving institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities.
26. Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations were included among eligible applicants.
27. Are U.S. territories or regional organizations eligible?
Yes. The eligibility list included U.S. territories or possessions and regional organizations.
28. Where was the full announcement available?
The full announcement was linked through the NIH grants guide at the provided URL.
29. Who should be contacted for technical assistance related to the announcement link?
Technical assistance contacts were routed through the NIH Office of Extramural Research webmaster.
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