Opportunity Information: Apply for PAR 13 195
Apply for PAR 13 195
- The National Institutes of Health 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 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Apr 25, 2013 and posted on Apr 25, 2013.
- Applicants must submit their applications by May 7, 2016. (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: Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education County governments For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized) 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 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) State governments Special district governments Independent school districts Private institutions of higher education.
- 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 funding opportunity PAR 13-195, titled "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)," supports preclinical research projects that use model organisms to strengthen how well findings translate into human clinical trials for intellectual and developmental disabilities (IDD). The central idea is to close the gap between promising laboratory results and real-world treatment effects in people by improving the rigor, standardization, and predictive value of preclinical testing in animals or other model systems used to study neurodevelopmental disorders.
A major emphasis of the announcement is on developing and strengthening the tools used to judge whether a treatment is working in a model organism in ways that meaningfully reflect human outcomes. Applicants are encouraged to create, validate, and/or calibrate outcome measures that can be used reliably across studies, including surrogate markers and biomarkers. In this context, the work should not just produce interesting biological observations, but should aim to generate measures that are objective, reproducible, and informative for planning or interpreting human trials. The expectation is that these readouts in model organisms will be tied as directly as possible to clinically relevant domains in IDD, improving confidence that a therapy showing benefit preclinically has a better chance of showing benefit when tested in people.
The FOA also allows and encourages more trial-like preclinical study designs. Projects may propose rigorous, controlled, and standardized preclinical animal trials intended to predict safety, toxicity, and efficacy, or to conduct an independent validation of efficacy before moving a candidate therapy into human testing. This reflects a push toward higher-quality preclinical evidence, including careful controls and study procedures that resemble the discipline of clinical trials, with the broader goal of reducing false leads and improving decision-making about which candidate compounds should advance to clinical evaluation.
Overall, the stated goal is to accelerate and improve preclinical testing of candidate treatments and therapeutic compounds so that the most promising approaches can move into clinical trials more efficiently and with better supporting evidence. The announcement also notes that applicants who are interested in related work may want to look at the companion opportunity focused on outcome measures for use directly in treatment trials of individuals with IDD, signaling that NIH is trying to build a pipeline where measurement strategies and therapeutic testing reinforce one another from preclinical studies through human trials.
Administratively, this is a discretionary grant opportunity using the NIH Research Project Grant (R01) mechanism, within the broad activity category of Health, Income Security, and Social Services. It is associated with CFDA 93.865 (Child Health and Human Development Extramural Research), and it does not require cost sharing or matching. The posting and creation date were April 25, 2013, with an original and current closing date of May 7, 2016, and an archive date of June 7, 2016. The listed award ceiling is $499,999.
Eligibility is broad and includes many types of organizations and institutions, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations (including small businesses and other than small businesses), and various government entities (state, county, city/township, special district). It also includes Tribal governments and Tribal organizations, public housing authorities/Indian housing authorities, independent school districts, and other applicants as specified. The eligibility statement explicitly includes a wide range of designated institution types (for example, HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities), as well as faith-based and community-based organizations where applicable. Foreign organizations and foreign components are allowed under NIH policy, including non-U.S. entities, non-U.S. components of U.S. organizations, and foreign components as defined in the NIH Grants Policy Statement.
The sponsoring agency is the National Institutes of Health. The full announcement was provided through the NIH grants guide (linked in the source as http://grants.nih.gov/grants/guide/pa-files/PAR-13-195.html). For technical access issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity PAR-13-195?
PAR-13-195 is an NIH Funding Opportunity Announcement (FOA) titled "Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01)." It supports preclinical research projects that use model organisms to improve how well preclinical findings translate into human clinical trials for intellectual and developmental disabilities (IDD).
What is the main goal of this FOA?
The stated goal is to close the gap between promising laboratory results and real-world treatment effects in people by improving the rigor, standardization, and predictive value of preclinical testing in model organisms used to study neurodevelopmental disorders associated with IDD. The FOA aims to accelerate and improve preclinical testing so that the most promising treatments can move into clinical trials more efficiently and with stronger supporting evidence.
What kinds of research does PAR-13-195 support?
The FOA supports preclinical research using model organisms to strengthen the ability of preclinical studies to predict clinical trial outcomes for IDD-related disorders. It emphasizes projects that improve the quality and usefulness of preclinical evidence for deciding whether a candidate therapy should advance toward human testing.
Why does the FOA emphasize model organisms?
Model organisms are used as preclinical systems to test candidate therapies and understand neurodevelopmental disorders. This FOA specifically focuses on making those model systems more informative for human clinical trials by improving how outcomes are measured and how studies are designed and standardized.
What is meant by "improving translation" from preclinical studies to human trials?
In this FOA, improving translation means increasing confidence that a therapy showing benefit in a model organism is more likely to show benefit when tested in people. The approach highlighted includes better outcome measures, more rigorous and standardized testing, and study designs that better predict safety, toxicity, and efficacy relevant to human trials.
What is the FOA looking for regarding outcome measures?
A major emphasis is on developing, strengthening, and improving tools used to judge whether a treatment is working in a model organism in ways that meaningfully reflect human outcomes. Applicants are encouraged to create, validate, and/or calibrate outcome measures that can be used reliably across studies, including surrogate markers and biomarkers.
Does the FOA support biomarker and surrogate marker work?
Yes. The FOA explicitly encourages the development and strengthening of outcome measures, including surrogate markers and biomarkers, as long as these readouts are objective, reproducible, and informative for planning or interpreting human clinical trials.
How closely should preclinical outcomes relate to clinical outcomes in IDD?
The FOA states that the readouts in model organisms should be tied as directly as possible to clinically relevant domains in IDD. The intent is to improve confidence that preclinical benefits align with domains that matter in human trials.
Is the FOA interested in general biological observations in model organisms?
The emphasis is not on producing only interesting biological observations. The FOA expects measures and readouts that are objective, reproducible, and useful for planning or interpreting human trials, with a focus on improving predictive value and standardization.
Does PAR-13-195 encourage trial-like preclinical study designs?
Yes. The FOA allows and encourages more trial-like preclinical study designs, including rigorous, controlled, and standardized preclinical animal trials intended to predict safety, toxicity, and efficacy.
Can projects propose independent validation of efficacy before human testing?
Yes. The FOA notes that projects may propose independent validation of efficacy before moving a candidate therapy into human testing, reflecting a push toward higher-quality preclinical evidence and fewer false leads.
What is the purpose of making preclinical studies more standardized and rigorous?
The broader goal is to reduce false leads and improve decision-making about which candidate compounds should advance to clinical evaluation. The FOA promotes careful controls and study procedures that resemble the discipline of clinical trials.
What NIH grant mechanism is used for this opportunity?
This opportunity uses the NIH Research Project Grant (R01) mechanism.
Is this a discretionary grant opportunity?
Yes. The opportunity is described as a discretionary grant opportunity.
What is the activity category listed for this opportunity?
The broad activity category is Health, Income Security, and Social Services.
What CFDA number is associated with PAR-13-195?
The FOA is associated with CFDA 93.865 (Child Health and Human Development Extramural Research).
Is cost sharing or matching required?
No. The listing specifies that cost sharing or matching is not required.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $499,999.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) nonprofits); for-profit organizations (including small businesses and other than small businesses); and government entities such as state, county, city/township, and special district governments.
Are Tribal governments and Tribal organizations eligible?
Yes. The eligibility statement explicitly includes Tribal governments and Tribal organizations.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are included in the eligibility list.
Are independent school districts eligible?
Yes. Independent school districts are included in the eligibility list.
Does the FOA explicitly include certain designated institution types?
Yes. The eligibility statement explicitly includes a wide range of designated institution types, including HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities.
Are faith-based and community-based organizations eligible?
Yes, where applicable. The eligibility statement notes faith-based and community-based organizations.
Are foreign organizations or foreign components allowed?
Yes. Foreign organizations and foreign components are allowed under NIH policy, including non-U.S. entities, non-U.S. components of U.S. organizations, and foreign components as defined in the NIH Grants Policy Statement.
Which agency sponsors this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
Where can applicants find the full announcement text?
The full announcement was provided through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-195.html
What are the key dates listed for this FOA?
The posting and creation date is April 25, 2013. The original and current closing date is May 7, 2016. The archive date is June 7, 2016.
Is this opportunity still open based on the dates provided?
Based on the information provided, the closing date is May 7, 2016 and the archive date is June 7, 2016, indicating the opportunity is no longer active under those dates.
Is there a related or companion opportunity mentioned?
Yes. The announcement notes that applicants interested in related work may want to look at a companion opportunity focused on outcome measures for use directly in treatment trials of individuals with IDD, suggesting NIH is building a pipeline from preclinical measurement and testing through human trials.
Who should be contacted for technical access issues?
For technical access issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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