Opportunity Information: Apply for RFA HD 09 016
Apply for RFA HD 09 016
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Pharmacokinetic Research in Pediatric HIV/TB Co Infection (R21)" 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 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Mar 4, 2010 and posted on Mar 3, 2010.
- Applicants must submit their applications by Aug 24, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Special district governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education State governments Small businesses Native American tribal governments (Federally recognized) Independent school districts Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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) 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 grant opportunity "Pharmacokinetic Research in Pediatric HIV/TB Co-Infection (R21)" (Funding Opportunity Number RFA-HD-09-016) was created to push forward much-needed early stage research on how tuberculosis drugs behave in the bodies of children who are also living with HIV, and how those TB medicines interact with antiretroviral HIV treatments. The core problem this FOA is trying to address is that pediatric TB, especially in children with HIV, is harder to diagnose and manage than adult TB, and as a result the evidence base for dosing and drug interaction management in children is far less developed. The announcement, led by NICHD with co-support from NIMH, is essentially a call for exploratory studies that can close these knowledge gaps and help clinicians treat co-infected children more safely and effectively.
The scientific focus is pharmacokinetics (PK) and PK drug-drug interactions. Applicants are encouraged to study key questions such as whether standard pediatric dosing of anti-TB agents actually achieves therapeutic drug levels in HIV-infected children, and how common HIV/TB medication combinations change drug exposure (for example, by increasing toxicity risk or by lowering levels enough to jeopardize TB cure or HIV control). A notable emphasis is placed on central nervous system (CNS) tuberculosis, where successful treatment depends heavily on whether anti-TB drugs penetrate into the CNS at adequate concentrations. In practical terms, the FOA is looking for projects that can generate dosing and exposure data that are directly useful for optimizing real-world treatment regimens for children with HIV/TB co-infection, including situations where ART may alter TB drug levels (or vice versa).
This opportunity uses the NIH Exploratory/Developmental Research Grant (R21) mechanism, which is designed for earlier stage, higher-risk or proof-of-concept work that can establish feasibility, provide preliminary PK/interaction estimates, or generate data that justify larger clinical studies later. The FOA notes that it is issued in parallel with an R01 announcement of the same scientific scope (RFA-HD-09-015), signaling that the R21 is meant to support smaller, developmental projects while the R01 would support more mature, full-scale studies.
In terms of funding, NICHD planned to commit $250,000 in total costs and NIMH planned to commit $150,000 in total costs in fiscal year 2010. The agencies anticipated making one to two awards, depending on both the availability of funds and whether enough high-quality, meritorious applications were submitted.
Eligibility is broad and includes many types of U.S. and non-U.S. institutions and organizations. Eligible applicants listed include public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), and a range of government entities (state, county, city/township, special districts), as well as independent school districts and public housing authorities/Indian housing authorities. The FOA also explicitly includes various mission-focused or underserved-serving institutions and entities, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, tribal governments and tribal organizations, faith-based or community-based organizations, regional organizations, U.S. territories/possessions, and foreign (non-U.S.) organizations.
Administratively, the FOA was posted in early March 2010, with an original and current closing date of August 24, 2010, and it was archived on September 24, 2010. The CFDA program areas tied to it include Mental Health Research Grants (93.242) and Child Health and Human Development Extramural Research (93.865). There was no cost sharing or matching requirement. For full details, NIH referenced the complete announcement at the grants.nih.gov link provided in the notice, and directed technical access issues to the NIH Office of Extramural Research (OER) webmaster contact.
Frequently Asked Questions (FAQs)
What is the title and identifier of this NIH funding opportunity?
The opportunity is titled "Pharmacokinetic Research in Pediatric HIV/TB Co-Infection (R21)" and the Funding Opportunity Number is RFA-HD-09-016.
What is the main purpose of this grant opportunity?
This FOA aims to advance early stage research on how tuberculosis (TB) drugs behave in the bodies of children who also have HIV, and how TB medicines interact with antiretroviral therapy (ART). The goal is to close evidence gaps that affect safe and effective treatment of pediatric HIV/TB co-infection.
What problem is the FOA trying to address?
The FOA highlights that pediatric TB, especially in children with HIV, is harder to diagnose and manage than adult TB. As a result, the evidence base for pediatric dosing and drug interaction management is less developed. This announcement is intended to help generate data that can strengthen that evidence base.
What scientific area is the primary focus of the FOA?
The focus is pharmacokinetics (PK) and PK drug-drug interactions in pediatric HIV/TB co-infection.
What types of research questions does the FOA encourage?
The FOA encourages studies such as whether standard pediatric dosing of anti-TB agents achieves therapeutic drug levels in HIV-infected children, and how common combinations of HIV and TB medications alter drug exposure in ways that could increase toxicity or reduce efficacy (for TB cure or HIV control).
Does the FOA emphasize any specific form of TB?
Yes. The FOA places notable emphasis on central nervous system (CNS) tuberculosis, where treatment success depends in part on whether anti-TB drugs reach adequate concentrations in the CNS.
What kinds of outcomes or data is the FOA looking for?
The FOA is looking for dosing and exposure data that can be used to optimize real-world treatment regimens for children with HIV/TB co-infection, including scenarios where ART affects TB drug levels or TB drugs affect ART exposure.
What grant mechanism is used for this opportunity?
This opportunity uses the NIH Exploratory/Developmental Research Grant (R21) mechanism.
What does the R21 mechanism imply about the type of projects NIH expects?
R21 awards are intended for earlier stage, higher-risk, or proof-of-concept work. For this FOA, that includes studies designed to establish feasibility, generate preliminary PK or interaction estimates, or produce data that can justify larger clinical studies later.
Is there a related NIH opportunity with the same scientific scope?
Yes. The FOA notes it was issued in parallel with an R01 announcement of the same scientific scope: RFA-HD-09-015. The R21 is positioned for smaller, developmental projects, while the R01 would support more mature, full-scale studies.
Which NIH Institutes or Centers led and supported this FOA?
The announcement was led by NICHD (Eunice Kennedy Shriver National Institute of Child Health and Human Development) with co-support from NIMH (National Institute of Mental Health).
How much funding did the NIH components plan to commit?
NICHD planned to commit $250,000 in total costs and NIMH planned to commit $150,000 in total costs in fiscal year 2010.
How many awards were anticipated?
The agencies anticipated making one to two awards, depending on availability of funds and whether enough high-quality, meritorious applications were submitted.
Is cost sharing or matching required?
No. The FOA states there was no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. institutions and organizations. The FOA lists eligible applicants such as public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and a range of government entities (state, county, city/township, and special districts), plus independent school districts and public housing authorities/Indian housing authorities.
Are underserved-serving or mission-focused institutions explicitly included?
Yes. The FOA explicitly includes HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, tribal governments and tribal organizations, as well as faith-based or community-based organizations, regional organizations, and U.S. territories/possessions.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA explicitly includes foreign (non-U.S.) organizations among eligible applicants.
When was this FOA posted, and what were the key dates?
The FOA was posted in early March 2010. The original and current closing date was August 24, 2010. It was archived on September 24, 2010.
Which CFDA program areas are associated with this opportunity?
The CFDA program areas tied to it include Mental Health Research Grants (93.242) and Child Health and Human Development Extramural Research (93.865).
Where were applicants directed to find the full announcement details?
NIH referenced the complete announcement at the grants.nih.gov link provided in the notice.
Who should be contacted for technical access issues with the FOA posting?
For technical access issues, NIH directed inquiries to the NIH Office of Extramural Research (OER) webmaster contact.
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