Opportunity Information: Apply for PAR 11 246
Apply for PAR 11 246
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology (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 Jul 12, 2011 and posted on Jul 12, 2011.
- Applicants must submit their applications by May 15, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses State governments For profit organizations other than small businesses City or township governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Private institutions of higher education.
- 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 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.
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Opportunity Summary:
The grant opportunity titled Translational Research in Pediatric and Obstetric Pharmacology (R01) is a National Institutes of Health (NIH) discretionary funding announcement designed to support research that improves how medicines are studied, used, and developed for two groups that are often underrepresented in drug research: children across different developmental stages and pregnant women, including effects on the developing fetus. The central focus is translational and clinical research, meaning projects should connect basic scientific insights to practical medical applications, and it explicitly allows clinical research and clinical trials when they are needed to answer important questions about drug action, response, and safety in these populations.
At its core, the FOA aims to build stronger evidence about why drugs work the way they do (mechanisms of action), how different patients respond (variability in response, which can include developmental biology and pregnancy-related physiologic changes), and what risks may exist (safety, adverse effects, and fetal or neonatal outcomes). For pediatric studies, the emphasis is on the fact that infants, children, and adolescents are not simply smaller adults; drug absorption, metabolism, distribution, and elimination can shift dramatically as children grow, and dosing and safety profiles can change accordingly. For obstetric pharmacology, the FOA recognizes that pregnancy can meaningfully alter pharmacokinetics and pharmacodynamics, and that medication exposure may affect both the pregnant individual and the fetus, making careful research essential for appropriate use.
The overall goals are strongly patient-centered and clinically practical. NIH is looking for projects that can improve the safety and effectiveness of medications already in use for pediatric or obstetric patients, as well as projects that help speed the development of new drugs or enable safer, more precise use of existing drugs. A recurring theme is tailored therapy: generating the knowledge needed to individualize treatment to meet real-world clinical needs in these special populations, where clinicians often have limited data and must make decisions with uncertainty. The intent is to reduce that uncertainty by producing better evidence on dosing, therapeutic windows, response predictors, and safety monitoring strategies.
This opportunity uses the R01 mechanism, which is the NIH research project grant intended for substantial, hypothesis-driven programs of research. The Funding Opportunity Number is PAR-11-246, and it falls under the Health category and the CFDA listing 93.865 (Child Health and Human Development Extramural Research), indicating alignment with NICHD-related priorities even though it is presented as an NIH opportunity. The announcement was posted on July 12, 2011, and it had an original and current closing date of May 15, 2013, with an archive date of June 15, 2013, meaning it was time-limited and is now closed as a historical record.
Eligibility is broad and intentionally inclusive across public, private, academic, nonprofit, for-profit, and government settings. Eligible applicants include state governments, county and city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Higher education institutions are eligible on both the public and private side, and nonprofits can apply whether or not they have formal 501(c)(3) status (with the usual NIH requirements applying). For-profit organizations, including small businesses and other for-profit entities, are also eligible. The FOA also highlights eligibility for a range of mission-driven and historically underrepresented institutions and communities, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), tribal governments and organizations (both federally recognized and other-than-federally recognized categories are referenced), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
A notable feature is that foreign participation is allowed. Non-U.S. entities (foreign institutions) may apply, and non-U.S. components of U.S. organizations are also eligible. This matters for pediatric and obstetric pharmacology because important clinical cohorts, disease burdens, and medication-use patterns can be global, and cross-national research can strengthen generalizability, enrollment feasibility, and scientific insight.
The FOA does not require cost sharing or matching, which is consistent with many NIH research grants and lowers the barrier for institutions that might not have large discretionary resources. Administrative support and access information are routed through NIH’s Office of Extramural Research (OER). For technical issues accessing or linking to the full announcement, the contact listed is the NIH OER Webmaster at FBOWebmaster@OD.NIH.GOV, and the full announcement link is provided through the NIH grants guide page.
In practical terms, a competitive project under this FOA would be expected to address a clear translational or clinical question that directly informs medication use in children or pregnancy. That could include defining developmental or pregnancy-specific mechanisms that change drug response, identifying biomarkers or clinical predictors that help tailor therapy, evaluating dosing strategies that better match physiology at different ages or gestational stages, or conducting clinical studies that close evidence gaps around efficacy and safety. The throughline is impact: generating results that help clinicians and researchers move toward safer, more effective, and more individualized pharmacotherapy for pediatric and obstetric patients.
Frequently Asked Questions (FAQs)
What is the "Translational Research in Pediatric and Obstetric Pharmacology (R01)" grant opportunity?
It is a National Institutes of Health (NIH) discretionary funding announcement that supports translational and clinical research to improve how medicines are studied, used, and developed for children (across developmental stages) and for pregnant women, including consideration of effects on the developing fetus.
What is the funding opportunity number?
The Funding Opportunity Number is PAR-11-246.
What funding mechanism does this opportunity use?
This opportunity uses the NIH R01 mechanism, which is intended for substantial, hypothesis-driven research programs (research project grants).
What is the main purpose of this FOA?
The FOA aims to build stronger evidence about medication action, response, and safety in pediatric and obstetric populations that are often underrepresented in drug research, with an emphasis on producing clinically useful knowledge that can reduce uncertainty in real-world medical decision-making.
What types of research does this FOA emphasize?
The focus is on translational and clinical research that connects basic scientific insights to practical medical applications. The FOA explicitly allows clinical research and clinical trials when needed to answer important questions about drug action, response, and safety in children and pregnant women.
Are clinical trials allowed under this FOA?
Yes. The announcement explicitly allows clinical research and clinical trials when they are needed to answer key questions about drug action, variability in response, and safety in the target populations.
Which patient populations are targeted?
The FOA targets (1) children across different developmental stages (including infants, children, and adolescents) and (2) pregnant women, including consideration of medication effects on the developing fetus and related fetal or neonatal outcomes.
Why does the FOA treat children as a distinct focus for pharmacology research?
Because infants, children, and adolescents are not simply smaller adults. Drug absorption, metabolism, distribution, and elimination can shift as children grow, which can change dosing needs and safety profiles across development.
Why is obstetric (pregnancy) pharmacology a focus area?
Pregnancy can meaningfully alter pharmacokinetics and pharmacodynamics, and medication exposure can affect both the pregnant individual and the fetus. The FOA highlights the need for careful research to support appropriate medication use during pregnancy.
What kinds of scientific questions is NIH looking for projects to answer?
Projects are expected to strengthen evidence around mechanisms of action, variability in patient response (including developmental biology and pregnancy-related physiologic changes), and safety risks (including adverse effects and fetal or neonatal outcomes).
What does "translational" mean in the context of this FOA?
It means research should connect basic scientific insights to practical clinical applications, with the intent of generating results that inform real-world medication use, dosing, safety monitoring, and individualized therapy decisions for pediatric and obstetric patients.
What are the intended practical outcomes of funded projects?
NIH is looking for research that improves the safety and effectiveness of medications already used in pediatric or obstetric care, helps speed development of new drugs, or enables safer and more precise use of existing drugs through better evidence on dosing, therapeutic windows, response predictors, and safety monitoring.
Does this FOA support research on existing medications, new drug development, or both?
Both. The FOA emphasizes improving safety and effectiveness of medications already in use, and also supports work that helps accelerate development of new drugs or improves the precision and safety of existing therapies.
What is meant by "tailored therapy" in this opportunity?
It refers to generating knowledge needed to individualize treatment to patient needs in children and pregnancy, such as identifying predictors of response, aligning dosing to developmental or gestational physiology, and improving monitoring strategies to reduce risk.
What is the CFDA listing associated with this opportunity?
The CFDA listing is 93.865 (Child Health and Human Development Extramural Research).
Which category does this opportunity fall under?
The opportunity is listed under the Health category.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions, academic organizations, nonprofits (with or without formal 501(c)(3) status, subject to NIH requirements), for-profit organizations (including small businesses), and government entities.
Which U.S. government entities are eligible applicants?
Eligible applicants include state governments; county, city, or township governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities.
Are colleges and universities eligible?
Yes. Higher education institutions are eligible, including both public/state-controlled institutions and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Nonprofits can apply whether or not they have formal 501(c)(3) status, with standard NIH requirements applying.
Are for-profit organizations eligible?
Yes. For-profit organizations, including small businesses and other for-profit entities, are eligible.
Does the FOA highlight eligibility for specific institution types (for example, minority-serving institutions)?
Yes. The FOA highlights eligibility for institutions and communities including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), tribal governments and organizations, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
Is foreign participation allowed?
Yes. Non-U.S. entities (foreign institutions) may apply, and non-U.S. components of U.S. organizations are also eligible.
Why might foreign participation be important for this research area?
The FOA notes that pediatric and obstetric pharmacology questions can be global in nature, and cross-national research can strengthen generalizability, support enrollment feasibility, and provide additional scientific insight.
When was this funding announcement posted?
The announcement was posted on July 12, 2011.
What were the closing and archive dates for this opportunity?
The original and current closing date was May 15, 2013, and the archive date was June 15, 2013.
Is this FOA still open for applications?
No. Based on the provided dates, it was time-limited and is now closed and archived as a historical record.
Where can applicants find administrative support and access information?
Administrative support and access information are routed through NIH's Office of Extramural Research (OER), and the full announcement is available via the NIH grants guide page link referenced in the opportunity details.
Who should be contacted for technical issues accessing or linking to the full announcement?
For technical issues accessing or linking to the full announcement, the contact listed is the NIH OER Webmaster at FBOWebmaster@OD.NIH.GOV.
What would a competitive project under this FOA generally look like?
A competitive project would address a clear translational or clinical question directly informing medication use in children or pregnancy. Examples described include defining developmental or pregnancy-specific mechanisms that change drug response, identifying biomarkers or clinical predictors to tailor therapy, evaluating dosing strategies aligned with age or gestational physiology, or conducting clinical studies that close evidence gaps around efficacy and safety.
What is the common "throughline" across the projects NIH wants to support?
Impact on patient care: generating results that help clinicians and researchers move toward safer, more effective, and more individualized pharmacotherapy for pediatric and obstetric patients, with better evidence to guide dosing, response prediction, and safety monitoring.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 246) also looked into and applied for these:
| Funding Opportunity |
|---|
| Pediatric Scientist Development Program (PSDP) K12 Apply for RFA HD 12 209 Funding Number: RFA HD 12 209 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Rehabilitation Research Career Development Programs (K12) Apply for RFA HD 12 208 Funding Number: RFA HD 12 208 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Ethical, Legal, and Social Implications (ELSI) of Genomic Research Exploratory/Developmental Research Grant Award (R21) Apply for PA 11 251 Funding Number: PA 11 251 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Systems Developmental Biology for Understanding Embryonic Development and the Ontogeny of Structural Birth Defects (R01) Apply for PAR 11 257 Funding Number: PAR 11 257 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Biomedical/Biobehavioral Research Administration Development (BRAD) Award G11 Apply for PAR 11 270 Funding Number: PAR 11 270 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Psychosocial/Behavioral Interventions and Services Research in Autism Spectrum Disorders (R34) Apply for PA 11 283 Funding Number: PA 11 283 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $225,000 |
| Educational Programs for Demography and Population Science, Family Planning and Contraception, and Reproductive Research (R25) Apply for PAR 11 292 Funding Number: PAR 11 292 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01) Apply for PAR 11 301 Funding Number: PAR 11 301 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03) Apply for PAR 11 302 Funding Number: PAR 11 302 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21) Apply for PAR 11 303 Funding Number: PAR 11 303 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems SBIR (R43) Apply for PAR 11 304 Funding Number: PAR 11 304 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41) Apply for PAR 11 305 Funding Number: PAR 11 305 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $100,000 |
| Biomarkers Bridging Pediatric and Adult Therapeutics (R03) Apply for PAR 11 323 Funding Number: PAR 11 323 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| NIH/PEPFAR Collaboration for Advancing Implementation Science in Prevention of Maternal Child HIV Transmission (PMTCT) (R01) Apply for RFA HD 12 210 Funding Number: RFA HD 12 210 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Research Infrastructure for Demographic and Behavioral Population Science (R24) Apply for RFA HD 12 186 Funding Number: RFA HD 12 186 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Improving Adherence to Treatment Regimens for HIV Positive Adolescents and Young Adults (R01) Apply for RFA HD 12 206 Funding Number: RFA HD 12 206 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $400,000 |
| Developmental Mechanisms of Human Structural Birth Defects (P01) Apply for PAR 12 034 Funding Number: PAR 12 034 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Advanced Neural Prosthetics Research and Development (U01) Apply for PAR 12 053 Funding Number: PAR 12 053 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,000,000 |
| Enhancing Developmental Biology Research at Undergraduate Institutions Academic Research Enhancement Award (R15) Apply for PAR 12 057 Funding Number: PAR 12 057 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $300,000 |
| Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54) Apply for RFA HD 13 005 Funding Number: RFA HD 13 005 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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