Opportunity Information: Apply for PAR 16 215
Apply for PAR 16 215
- The HHS-NIH11 in the health, income security and social services sector is offering a public funding opportunity titled "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865,.
- This funding opportunity was created on Apr 26, 2016 and posted on Apr 26, 2016.
- Applicants must submit their applications by Sep 07, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $499,999.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIH funding opportunity PAR-16-215, titled "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)," supports preclinical studies that use model organisms to improve how potential treatments for neurodevelopmental disorders are evaluated before they reach human testing. The central idea is to strengthen the bridge between animal or other model-based findings and real-world clinical trial outcomes for people with intellectual and developmental disabilities (IDD). Rather than simply testing whether an intervention changes a behavior in a lab setting, this FOA emphasizes building the kinds of measures and evidence that can meaningfully predict whether a therapy is likely to be safe and effective in humans.
A major focus of the announcement is the development, validation, and calibration of outcome measures, surrogate markers, and biomarkers in model organisms. In practice, this means applicants are expected to propose approaches that identify measurable signals in animals (or other relevant models) that align with clinically meaningful endpoints in people. These can include behavioral readouts, physiological measures, imaging-based metrics, electrophysiological signatures, molecular markers, or other quantifiable indicators that could serve as proxies for treatment response. The FOA is explicitly oriented toward translational relevance: proposed measures should be designed and tested with an eye toward how they could inform human trials, including whether they can be standardized, reproduced across sites, and interpreted in ways that clinicians and clinical researchers can use.
In addition to measurement and biomarker work, the FOA allows and encourages rigorous, controlled, and standardized preclinical trials in animals aimed at improving prediction of safety, toxicity, and efficacy. This includes carefully designed studies that resemble the discipline of human clinical trials more than traditional exploratory animal experiments: clear hypotheses, appropriate controls, randomization and blinding when feasible, consistent dosing and administration protocols, and robust statistical planning. Another supported use case is independent validation of efficacy in animals prior to initiating human clinical trials, which speaks to the broader goal of reducing false positives and improving confidence that a candidate therapy has a reproducible effect before it advances.
The overall goal is to accelerate the movement of promising therapies into clinical testing while improving the quality of the evidence used to justify that transition. By funding work that tightens preclinical methods, standardizes readouts, and improves biomarker and outcome measure translation, NIH is aiming to make preclinical pipelines more predictive and efficient. This can help the field avoid costly and ethically challenging human trials based on weak preclinical foundations, and it can also help identify the most promising compounds sooner.
This is an R01 research grant mechanism within NIH (agency listed as HHS-NIH11) under CFDA numbers 93.865. The opportunity is categorized as discretionary funding, with an award ceiling listed at $499,999. Eligibility is broad and includes various levels of government entities (state, county, city/township, special districts), independent school districts, public and private institutions of higher education, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with and without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), and other applicants as clarified in the full FOA text. The FOA was posted and created on April 26, 2016, with a listed closing date of September 7, 2019.
Applicants who are particularly focused on clinical-trial-ready outcome measures in people with IDD, rather than primarily model-organism development and validation, are pointed to a related funding opportunity, PAR-16-216, titled "Outcome Measures For Use In Treatment Trials of Individuals with Intellectual and Developmental Disabilities."
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity PAR-16-215?
PAR-16-215 is an NIH R01 funding opportunity titled "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)." It supports preclinical research that uses model organisms to improve how well preclinical findings predict treatment outcomes in people with intellectual and developmental disabilities (IDD).
What is the main goal of this funding opportunity?
The main goal is to strengthen the bridge between model-organism research and real-world clinical trial outcomes for people with IDD. The emphasis is on generating preclinical evidence, measures, and markers that can meaningfully predict whether a therapy is likely to be safe and effective in humans.
What kinds of studies does PAR-16-215 support?
This FOA supports preclinical studies in model organisms that improve evaluation of potential treatments for neurodevelopmental disorders before human testing. It particularly emphasizes (1) development and validation of outcome measures, surrogate markers, and biomarkers in model organisms, and (2) rigorous, controlled, standardized preclinical trials in animals designed to better predict safety, toxicity, and efficacy.
What does the FOA mean by improving "predictability" for human outcomes?
In this context, improving predictability means designing preclinical measures and evidence so they align with clinically meaningful endpoints in people. Instead of only showing that an intervention changes a lab behavior, applicants are expected to build measures and supporting data that can help forecast whether similar benefits (and acceptable safety) are likely in human clinical trials.
Is the focus only on testing whether an intervention changes behavior in animals?
No. The FOA specifically emphasizes moving beyond simple demonstrations of behavioral change in a lab setting. It prioritizes measures and evidence that can be translated and interpreted in ways that are relevant to clinicians and clinical researchers planning or running human trials.
What are "outcome measures" in model organisms under this FOA?
Outcome measures are measurable readouts in model organisms used to assess treatment effects. Under PAR-16-215, the expectation is that these measures are developed, validated, and calibrated with translational relevance, meaning they are designed to relate to clinically meaningful endpoints in people with IDD.
What are surrogate markers and biomarkers in the context of PAR-16-215?
Surrogate markers and biomarkers are quantifiable signals in model organisms that may serve as proxies for treatment response. The FOA highlights developing and validating these signals so they align with outcomes that matter clinically, and so they can be used to better justify and design human testing.
What types of biomarkers or indicators are mentioned as relevant?
The FOA describes a broad range of potential indicators, including behavioral readouts, physiological measures, imaging-based metrics, electrophysiological signatures, molecular markers, and other quantifiable indicators that could serve as proxies for treatment response.
What does "development, validation, and calibration" mean for measures and biomarkers?
Based on the FOA description: development refers to creating or adapting measures/markers in model organisms; validation refers to demonstrating that the measure is meaningful and supports translational relevance; calibration refers to refining the measure so it aligns with clinically meaningful endpoints and can be interpreted in ways that inform human trials.
Does PAR-16-215 support preclinical trials that look more like human clinical trials?
Yes. The FOA allows and encourages rigorous, controlled, and standardized preclinical trials in animals. It highlights designs that resemble the discipline of human clinical trials, including clear hypotheses, appropriate controls, randomization and blinding when feasible, consistent dosing and administration protocols, and robust statistical planning.
Is independent validation of efficacy in animals supported?
Yes. The FOA notes that independent validation of efficacy in animals prior to initiating human clinical trials is a supported use case, aligning with the goal of reducing false positives and improving confidence before moving to human testing.
Why does the FOA emphasize standardization and reproducibility?
The FOA is oriented toward translational relevance and emphasizes that proposed measures should be designed and tested with consideration for whether they can be standardized, reproduced across sites, and interpreted in ways that clinicians and clinical researchers can use.
How does this FOA aim to impact the therapy development pipeline?
It aims to accelerate movement of promising therapies into clinical testing while improving the quality of evidence used to justify that transition. By tightening preclinical methods and improving translation of readouts and biomarkers, the FOA is intended to make preclinical pipelines more predictive and efficient.
How could this FOA help avoid weakly supported human trials?
The FOA describes an intent to reduce costly and ethically challenging human trials based on weak preclinical foundations by improving preclinical rigor, standardizing readouts, and strengthening the link between model-organism findings and clinical outcomes.
What NIH grant mechanism is used for PAR-16-215?
PAR-16-215 uses the R01 research project grant mechanism.
Which agency is listed for this opportunity?
The agency is listed as HHS-NIH11.
What CFDA number(s) are associated with this opportunity?
The opportunity is associated with CFDA 93.865.
What is the funding category for this opportunity?
The opportunity is categorized as discretionary funding.
What is the listed award ceiling?
The award ceiling is listed at $499,999.
Who is eligible to apply?
Eligibility is described as broad. It includes various government entities (state, county, city/township, special districts), independent school districts, public and private institutions of higher education, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with and without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), and other applicants as clarified in the full FOA text.
Are for-profit organizations allowed to apply?
Yes. The eligibility list explicitly includes for-profit organizations, including small businesses and other for-profits.
Are nonprofit organizations required to have 501(c)(3) status?
No. The eligibility list includes nonprofit organizations with and without 501(c)(3) status.
Can tribal governments or tribal organizations apply?
Yes. The eligibility list includes federally recognized tribal governments and other tribal organizations.
What are the posting and closing dates provided?
The FOA was posted and created on April 26, 2016, with a listed closing date of September 7, 2019.
What is the relationship between PAR-16-215 and PAR-16-216?
PAR-16-215 focuses on model-organism preclinical research intended to better predict treatment outcomes. Applicants whose work is more focused on clinical-trial-ready outcome measures in people with IDD (rather than primarily model-organism development and validation) are directed to a related opportunity: PAR-16-216, "Outcome Measures For Use In Treatment Trials of Individuals with Intellectual and Developmental Disabilities."
When should an applicant consider PAR-16-216 instead of PAR-16-215?
Based on the description provided, PAR-16-216 is the better fit when the main focus is outcome measures intended for use in treatment trials of individuals with IDD (human-focused measures), rather than development and validation of measures and biomarkers primarily in model organisms.
What kinds of practical design elements does the FOA highlight for supported preclinical trials?
The FOA highlights clear hypotheses, appropriate controls, randomization and blinding when feasible, consistent dosing and administration protocols, and robust statistical planning as examples of features that improve rigor and standardization in preclinical animal studies.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 215) also looked into and applied for these:
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|---|
| Outcome Measures for Use in Treatment Trials of Individuals with Intellectual and Developmental Disabilities (R01) Apply for PAR 16 216 Funding Number: PAR 16 216 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: $499,999 |
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| Characterization of the Adolescent Reproductive Transition (R01) Apply for PA 16 314 Funding Number: PA 16 314 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
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| Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R01) Apply for PA 16 311 Funding Number: PA 16 311 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Characterization of the Adolescent Reproductive Transition (R03) Apply for PA 16 316 Funding Number: PA 16 316 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Safety and Outcome Measures of Pain Medications Used in Children and Pregnant Women (R21) Apply for PA 16 312 Funding Number: PA 16 312 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: $200,000 |
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| Characterization of the Adolescent Reproductive Transition (R21) Apply for PA 16 315 Funding Number: PA 16 315 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Biophysical and Biomechanical Aspects of Embryonic Development (R01) Apply for PAR 16 325 Funding Number: PAR 16 325 Agency: HHS-NIH11 Category: Health, Income Security and Social Services Funding Amount: $500,000 |
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| Contraception Research Centers Program (U54) Apply for RFA HD 17 013 Funding Number: RFA HD 17 013 Agency: Department of Health and Human Services, National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $1,500,000 |
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