Opportunity Information: Apply for PAR 11 038
Apply for PAR 11 038
- 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): 93.242 Mental Health Research Grants 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Apr 25, 2013 and posted on Nov 17, 2010.
- Applicants must submit their applications by Apr 25, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses County governments State governments 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 Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Public housing authorities/Indian housing authorities Small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIH funding opportunity PAR 11 038 is an R01 (Research Project Grant) aimed at strengthening the preclinical evidence base for treatments targeting neurodevelopmental disorders associated with intellectual and developmental disabilities (IDD). It is sponsored by three NIH institutes: the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS). The central purpose is to improve how researchers use model organisms to predict whether a potential therapy is likely to be safe and effective in people, so that the most promising candidates can move into human clinical trials with a stronger foundation and a higher chance of success.
A key emphasis of the FOA is the development and refinement of translational tools in model systems. Applicants are expected to propose studies that develop, validate, and/or calibrate outcome measures, surrogate markers, and biomarkers in animals or other model organisms. The intent is not just to measure changes in a lab setting, but to identify measures that map meaningfully onto human clinical endpoints, so results in the model can inform trial design, participant selection, dosing rationale, and go/no-go decisions. In practical terms, this encourages projects that can show that what is being measured in the organism is reliable, sensitive to change, biologically relevant to the disorder, and plausibly comparable to measures used (or planned) in human IDD treatment trials.
In addition to measurement development, the FOA also supports rigorous, controlled, and standardized preclinical trials in animals. These projects may focus on predicting safety, toxicity, and efficacy, or they may provide independent validation of efficacy prior to launching a human study. The language about rigor and standardization signals a preference for study designs that reduce bias and improve reproducibility, such as careful control conditions, clear inclusion/exclusion criteria, appropriate powering, standardized protocols, and well-justified statistical plans. The overall goal is to raise the quality of preclinical testing so that translation from bench to clinic is faster, more reliable, and less likely to fail because preclinical signals were weak, poorly measured, or not comparable to human outcomes.
The opportunity is broad in who can apply. Eligibility includes a wide range of organizations and government entities, including public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special district, and independent school districts). It also explicitly includes tribal governments and tribal organizations, U.S. territories or possessions, and a variety of mission-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others. There is no cost sharing or matching requirement stated for this FOA.
From an administrative standpoint, this is a discretionary grant mechanism under health-related federal assistance categories. The CFDA numbers listed reflect the participating institutes and program areas: 93.242 (Mental Health Research Grants), 93.853 (Neurosciences and Neurological Disorders), and 93.865 (Child Health and Human Development Extramural Research). The opportunity was posted November 17, 2010, with an original closing date of May 7, 2013; the record indicates a current closing date of April 25, 2013 and an archive date of May 25, 2013, meaning it is an older, archived FOA rather than an active call today.
Finally, the announcement points applicants to a companion FOA released around the same time focused on outcome measures for use in treatment trials for individuals with IDD. That pairing highlights the broader NIH strategy behind this grant: align preclinical and clinical measurement approaches so that animal model findings can more directly inform human trial endpoints and decision-making. The full announcement was hosted on the NIH Grants Guide webpage for PAR 11 038, and the NIH Office of Extramural Research provided contact support for access or linking issues through the OER webmaster email listed in the notice.
Frequently Asked Questions (FAQs) - NIH PAR-11-038 (R01)
What is NIH PAR-11-038?
PAR-11-038 is an NIH Funding Opportunity Announcement (FOA) for an R01 (Research Project Grant). It focuses on strengthening the preclinical evidence base for treatments targeting neurodevelopmental disorders associated with intellectual and developmental disabilities (IDD), with an emphasis on improving the translational value of findings from model organisms to humans.
What is the main goal of this FOA?
The central purpose is to improve how researchers use model organisms to predict whether potential therapies are likely to be safe and effective in people. The intent is to help the most promising candidates move into human clinical trials with stronger preclinical support and a higher chance of success.
Which NIH institutes sponsor this opportunity?
This FOA is sponsored by three NIH institutes: the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS).
What grant mechanism does PAR-11-038 use?
PAR-11-038 uses the R01 (Research Project Grant) mechanism.
What types of research are emphasized?
The FOA emphasizes two major areas: (1) development and refinement of translational tools in model systems, and (2) rigorous, controlled, and standardized preclinical trials in animals to evaluate safety, toxicity, and efficacy or to independently validate efficacy before human studies.
What does "translational tools" mean in the context of this FOA?
In this FOA, translational tools refer to outcome measures, surrogate markers, and biomarkers developed, validated, and/or calibrated in animals or other model organisms in ways that map meaningfully onto human clinical endpoints. The expectation is that these measures help link model-system results to human trial decisions.
What kinds of measures are applicants expected to develop or refine?
Applicants are expected to propose studies that develop, validate, and/or calibrate outcome measures, surrogate markers, and biomarkers in model organisms, with a focus on measures that are biologically relevant, reliable, sensitive to change, and plausibly comparable to measures used (or planned) in human IDD treatment trials.
Why is alignment with human clinical endpoints important here?
The FOA is designed to encourage measures in model organisms that correspond to human clinical endpoints so that preclinical results can inform clinical trial design, participant selection, dosing rationale, and go/no-go decisions.
Does the FOA support preclinical efficacy testing in animals?
Yes. In addition to measurement development, the FOA supports rigorous, controlled, and standardized preclinical trials in animals. These studies may predict safety, toxicity, and efficacy and/or provide independent validation of efficacy before launching human studies.
What does the FOA mean by "rigorous, controlled, and standardized" preclinical trials?
The FOA signals a preference for designs intended to reduce bias and improve reproducibility. Examples described include careful control conditions, clear inclusion/exclusion criteria, appropriate powering, standardized protocols, and well-justified statistical plans.
How are results expected to be used in the translational pipeline?
The FOA frames preclinical work as a foundation for human clinical trials. The intended use of results includes informing trial design elements such as endpoints, participant selection approaches, dosing rationale, and decisions about whether a therapy is ready to advance (go/no-go decisions).
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special district, and independent school districts). It also includes tribal governments and tribal organizations, U.S. territories or possessions, and mission-focused institutions such as HBCUs, Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
Are small businesses eligible?
Yes. Small businesses are explicitly listed among eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations are eligible, and the eligibility list specifically notes for-profit organizations (other than small businesses) as eligible. Small businesses are also listed separately as eligible.
Are tribal governments and tribal organizations eligible?
Yes. The FOA explicitly includes tribal governments and tribal organizations among eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included in the eligibility description.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for this FOA.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.242 (Mental Health Research Grants), 93.853 (Neurosciences and Neurological Disorders), and 93.865 (Child Health and Human Development Extramural Research).
Is this FOA currently active?
Based on the information provided, it appears to be an older, archived FOA rather than an active call today. The opportunity was posted on November 17, 2010, with an original closing date of May 7, 2013; it lists a current closing date of April 25, 2013 and an archive date of May 25, 2013.
When was the FOA posted and when did it close?
The FOA was posted November 17, 2010. It lists an original closing date of May 7, 2013, a current closing date of April 25, 2013, and an archive date of May 25, 2013.
Where was the full announcement hosted?
The full announcement was hosted on the NIH Grants Guide webpage for PAR-11-038.
Is there a related or companion FOA mentioned?
Yes. The announcement points applicants to a companion FOA released around the same time focused on outcome measures for use in treatment trials for individuals with IDD.
Why does the FOA reference a companion announcement?
The pairing highlights an NIH strategy to align preclinical and clinical measurement approaches, so animal model findings can more directly inform human trial endpoints and decision-making.
Who is listed as a contact for access or linking issues?
The notice indicates that the NIH Office of Extramural Research (OER) provided contact support for access or linking issues through the OER webmaster email listed in the notice.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Understanding and Treating Co Morbid Conditions in Adolescents with Intellectual and Developmental Disabilities (R01)
Previous opportunity: Limited Competition Fogarty International Research Collaboration Behavioral and Social Sciences (FIRCA BSS) Research Award (R03)
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 038) also looked into and applied for these:
| Funding Opportunity |
|---|
| Understanding and Treating Co Morbid Conditions in Adolescents with Intellectual and Developmental Disabilities (R01) Apply for PA 11 039 Funding Number: PA 11 039 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Understanding and Treating Co Morbid Conditions in Adolescents with Intellectual and Developmental Disabilities (R03) Apply for PA 11 040 Funding Number: PA 11 040 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Understanding and Treating Co Morbid Conditions in Adolescents with Intellectual and Developmental Disabilities (R21) Apply for PA 11 041 Funding Number: PA 11 041 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54) Apply for RFA HD 12 169 Funding Number: RFA HD 12 169 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01) Apply for PAR 11 045 Funding Number: PAR 11 045 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Indo US Collaborative Program on Low Cost Medical Devices (R03) Apply for PAR 11 044 Funding Number: PAR 11 044 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Mechanisms of Adverse Drug Reactions in Children (R01) Apply for PAR 11 051 Funding Number: PAR 11 051 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Mechanisms of Adverse Drug Reactions in Children (R03) Apply for PAR 11 052 Funding Number: PAR 11 052 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Studies in Neonatal Hypoglycemia (R03) Apply for PA 11 054 Funding Number: PA 11 054 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Studies in Neonatal Hypoglycemia (R01) Apply for PA 11 053 Funding Number: PA 11 053 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Studies in Neonatal Hypoglycemia (R21) Apply for PA 11 055 Funding Number: PA 11 055 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Mentored Patient Oriented Research Career Development Award in Muscular Dystrophy Research (K23) Apply for PA 11 076 Funding Number: PA 11 076 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| NIH Pathway to Independence Award in Muscular Dystrophy Research (K99/R00) Apply for PA 11 078 Funding Number: PA 11 078 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Mentored Clinical Scientist Research Career Development Award in Muscular Dystrophy Research (K08) Apply for PA 11 077 Funding Number: PA 11 077 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Specialized Centers in Research in Pediatric Developmental Pharmacology Program (U54) Apply for RFA HD 10 026 Funding Number: RFA HD 10 026 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $500,000 |
| Research Infrastructure for Demographic and Behavioral Population Science (R24) Apply for RFA HD 10 020 Funding Number: RFA HD 10 020 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Rehabilitation Medicine Scientist Training (RMST) Program K12 Apply for RFA HD 11 081 Funding Number: RFA HD 11 081 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Indo US Program on Contraception and Reproductive Health Research (CRHR) R01 Apply for PAR 11 091 Funding Number: PAR 11 091 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Indo US Program on Maternal and Child Health and Human Development Research (MCHDR) (R03) Apply for PAR 11 092 Funding Number: PAR 11 092 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Scientific Meetings for Creating Collaborative Research Teams under the Indo US Program for Contraception and Reproductive Health Research (CRHR) R13 Apply for PAR 11 093 Funding Number: PAR 11 093 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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