Opportunity Information: Apply for PAR 11 051
Apply for PAR 11 051
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Mechanisms of Adverse Drug Reactions in Children (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Dec 2, 2010 and posted on Dec 2, 2010.
- Applicants must submit their applications by May 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments Native American tribal governments (Federally recognized) Special district governments Small businesses For profit organizations other than 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIH funding opportunity PAR-11-051, titled "Mechanisms of Adverse Drug Reactions in Children (R01)," was a discretionary research grant solicitation designed to push pediatric drug safety research beyond observation and into clear biological explanations. The central purpose of the announcement was to support hypothesis-driven projects that clarify why adverse drug reactions happen in children by identifying the molecular and cellular events that lead to toxicity. Rather than treating pediatric adverse reactions as smaller versions of adult problems, the FOA emphasized that children have distinct developmental biology, and that understanding pediatric risk requires studying age-related changes in drug handling and drug response.
A major scientific focus of this FOA was the role of ontogeny, meaning how normal growth and maturation alter the way a child absorbs, distributes, metabolizes, and responds to medications. The announcement encouraged research that characterizes pharmacogenetic and developmental differences in drug metabolizing enzymes (DMEs), as well as key biological systems that control drug effects and toxicities. Examples of the kinds of targets explicitly highlighted include transporters that move drugs into and out of tissues, ion channels that can be linked to serious cardiac or neurologic adverse events, receptors that mediate therapeutic and toxic responses, and signaling pathways that determine downstream cellular outcomes such as inflammation, apoptosis, or organ injury. In practice, the FOA was looking for studies that connect developmental stage and inherited variation (and potentially epigenetic regulation) to measurable toxicity mechanisms, helping explain why two children given the same drug can have dramatically different safety outcomes.
The opportunity used the R01 grant mechanism, signaling support for substantial, multi-year research projects that could generate a coherent body of mechanistic evidence. It fell within NIH health-related research support areas and was associated with CFDA numbers 93.310 (Trans-NIH Research Support) and 93.865 (Child Health and Human Development Extramural Research). The announcement did not require cost sharing or matching, which typically lowers barriers for applicants by not forcing them to provide non-federal funds to support the project.
Eligibility was broad and included many types of U.S. and non-U.S. organizations. Domestic applicants could include state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations both with and without 501(c)(3) status; independent school districts; public housing authorities/Indian housing authorities; small businesses; and for-profit organizations other than small businesses. The FOA also listed additional eligible entities such as federally recognized tribal governments and other tribal organizations, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (foreign) organizations. This breadth reflected NIH interest in pulling expertise from diverse research environments, including settings with specialized pediatric populations or unique pharmacogenomic resources.
In terms of timing, the FOA was posted on December 2, 2010, and remained open through an original and final closing date of May 7, 2014, after which it was archived on June 7, 2014. The sponsoring agency was the National Institutes of Health. For technical issues accessing the full announcement or resolving linking problems, the contact listed was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, and an additional information link was provided through the NIH Grants Guide website.
Overall, this FOA was aimed at improving pediatric medication safety by funding mechanistic research that explains adverse drug reactions through developmental biology plus genetic and epigenetic variation. The intended payoff was a stronger scientific foundation for predicting which children are at risk, identifying age-appropriate dosing or monitoring strategies, and ultimately reducing preventable drug-related harm in pediatric care.
Frequently Asked Questions (FAQs)
What is PAR-11-051?
PAR-11-051 is a National Institutes of Health (NIH) funding opportunity announcement titled "Mechanisms of Adverse Drug Reactions in Children (R01)." It was a discretionary research grant solicitation focused on pediatric drug safety research.
What is the main purpose of this funding opportunity?
The central purpose was to fund hypothesis-driven research that explains why adverse drug reactions occur in children by identifying the molecular and cellular events that lead to toxicity. The emphasis was on moving beyond observation to clear biological mechanisms.
What type of research approach did the FOA prioritize?
The FOA prioritized hypothesis-driven mechanistic studies that connect measurable biological events (molecular and cellular pathways) to pediatric drug toxicity. Projects were expected to build a coherent mechanistic explanation rather than simply describe clinical associations.
How did this FOA frame pediatric adverse drug reactions compared to adult adverse reactions?
The FOA explicitly emphasized that pediatric adverse drug reactions should not be treated as smaller versions of adult problems. It highlighted that children have distinct developmental biology, and pediatric risk assessment requires studying age-related differences in drug handling and drug response.
What is "ontogeny" and why was it important in this FOA?
Ontogeny refers to how normal growth and maturation affect how a child absorbs, distributes, metabolizes, and responds to medications. It was a major scientific focus because developmental stage can change both drug exposure and drug effect, influencing toxicity risk in children.
What kinds of biological factors and systems were encouraged as research targets?
The FOA encouraged research on developmental and pharmacogenetic differences in drug metabolizing enzymes (DMEs) and key biological systems that control drug effects and toxicities. Examples explicitly highlighted included transporters, ion channels, receptors, and signaling pathways that influence outcomes such as inflammation, apoptosis, or organ injury.
Did the FOA encourage research on genetics or inherited variation?
Yes. The FOA encouraged studies that connect inherited variation (pharmacogenetics) with developmental stage to explain toxicity mechanisms, including why two children receiving the same drug can have very different safety outcomes.
Was epigenetic regulation mentioned as relevant to the research goals?
Yes. The FOA indicated interest in connecting developmental stage and inherited variation, and it also noted epigenetic regulation as potentially relevant to measurable toxicity mechanisms.
What grant mechanism was used for this opportunity?
This opportunity used the NIH R01 research project grant mechanism, which signals support for substantial, multi-year research projects capable of producing a coherent body of mechanistic evidence.
Was cost sharing or matching required?
No. The FOA did not require cost sharing or matching, meaning applicants were not required to provide non-federal funds to support the project.
Who was eligible to apply?
Eligibility was broad and included many types of U.S. and non-U.S. organizations. Domestic eligibility included various levels of government entities, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), independent school districts, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses.
Were tribal organizations and minority-serving institutions eligible?
Yes. The FOA listed federally recognized tribal governments and other tribal organizations as eligible. It also included Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Were faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations were listed among eligible entities.
Were U.S. territories or possessions eligible?
Yes. The FOA included U.S. territories or possessions among eligible applicants.
Were non-U.S. (foreign) organizations eligible?
Yes. The FOA included non-domestic (foreign) organizations as eligible applicants.
When was this funding opportunity posted and when did it close?
The FOA was posted on December 2, 2010. It remained open through an original and final closing date of May 7, 2014, and it was archived on June 7, 2014.
Which agency sponsored the opportunity?
The sponsoring agency was the National Institutes of Health (NIH).
What CFDA numbers were associated with this FOA?
The FOA was associated with CFDA numbers 93.310 (Trans-NIH Research Support) and 93.865 (Child Health and Human Development Extramural Research).
What were the intended benefits or outcomes of the funded research?
The FOA aimed to improve pediatric medication safety by building a stronger mechanistic foundation for predicting which children are at risk, identifying age-appropriate dosing or monitoring strategies, and reducing preventable drug-related harm in pediatric care.
Who should be contacted for technical issues accessing the full announcement?
For technical issues accessing the full announcement or resolving linking problems, the contact listed was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Where was additional information made available?
An additional information link was provided through the NIH Grants Guide website.
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| 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 |
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| 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 |
| Scientific Meetings for Creating Collaborative Research Teams under the Indo US Program for Maternal Child Health and Human Development Research (MCHDR) R13 Apply for PAR 11 094 Funding Number: PAR 11 094 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Intellectual and Developmental Disabilities Research Centers 2011 (P30) Apply for RFA HD 10 022 Funding Number: RFA HD 10 022 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $750,000 |
| Education Research in Sleep Health and Sleep Circadian Biology (R25) Apply for PAR 11 098 Funding Number: PAR 11 098 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Learning Disabilities Research Centers (P50) Apply for RFA HD 12 202 Funding Number: RFA HD 12 202 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,200,000 |
| Disclosure of HIV Status to Children in Low and Middle Income Country Settings (R21) Apply for RFA HD 12 205 Funding Number: RFA HD 12 205 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Disclosure of HIV Status to Children in Low and Middle Income Country Settings (R01) Apply for RFA HD 12 197 Funding Number: RFA HD 12 197 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $300,000 |
| Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Predoctoral Fellows in PharmD/PhD Programs (F31) Apply for PA 11 129 Funding Number: PA 11 129 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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