Opportunity Information: Apply for RFA HD 09 006
Apply for RFA HD 09 006
- The National Institutes of Health in the education health income security and social services sector is offering a public funding opportunity titled "Limited Competition for the Pediatric HIV/AIDS Cohort Study (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.838 Lung Diseases Research 93.846 Arthritis, Musculoskeletal and Skin Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Sep 1, 2009 and posted on Sep 1, 2009.
- Applicants must submit their applications by Oct 28, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $14,250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $760,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education.
- Other Eligible Applicants include the following This is a limited solicitation made available to the grantees funded under the first PHACS FOA (RFA HD 05 018) as a recompetition for an additional award of up to five years. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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Opportunity Summary:
This grant opportunity, titled "Limited Competition for the Pediatric HIV/AIDS Cohort Study (U01)" (Funding Opportunity Number RFA-HD-09-006), is an NIH cooperative agreement meant to fund a competing renewal of the Pediatric HIV/AIDS Cohort Study (PHACS). It was issued primarily by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) with co-sponsorship and funding participation from several other NIH institutes, including NIDA, NIAID, NIMH, NINDS, NIDCD, NHLBI, and NIAAA. The overall goal is to continue and sustain the observational cohorts that were created and followed during PHACS's first competitive funding cycle, rather than launching an entirely new cohort effort. The emphasis is on maintaining continuity of follow-up and data collection so that longer-term outcomes can be measured in children and adolescents affected by HIV and HIV treatment exposure.
The scientific purpose centers on two major, long-running questions in pediatric HIV research. First, PHACS tracks the long-term safety of in utero exposure to combination antiretroviral therapy in children who were exposed to HIV during pregnancy but are not themselves infected (often referred to as HIV-exposed, uninfected children). As antiretroviral regimens have become more complex and more widely used in pregnancy, the need to understand possible delayed or subtle effects on growth, neurodevelopment, metabolism, organ function, hearing, and other health outcomes has become increasingly important. Second, PHACS examines how HIV infection acquired around birth, along with lifelong antiretroviral treatment, interact to affect the health and development of children and adolescents living with perinatal HIV. This includes looking at the combined effects of the virus itself, treatment toxicities, comorbid conditions, and developmental and behavioral health trajectories as participants move from childhood into adolescence and young adulthood.
The funding mechanism is the NIH Cooperative Research Project Grant (U01), which signals a collaborative model where NIH program staff typically have substantial scientific and operational involvement compared with a standard research project grant. The FOA anticipates making two awards total, structured around two central infrastructure components needed to run PHACS as a large, multi-site cohort program. One award is for the PHACS Coordinating Center (CC), which generally would be responsible for overall coordination functions such as study governance support, protocol coordination across sites, communications, meeting logistics, and harmonization of cohort activities. The second award is for the PHACS Data and Operations Center (DOC), which would typically handle the major operational backbone for a cohort effort, including data management, statistical support, operations, clinical site consortium management, and other large-scale infrastructure necessary to keep the observational cohorts running smoothly and consistently.
Funding for FY 2010 was projected at about $14.25 million in total costs (direct plus facilities and administrative costs), drawing from multiple institutes. The FOA lists intended institute commitments of approximately $5.4 million from NICHD, $3.4 million from NIDA, $2.0 million from NIAID, $1.2 million from NIMH, $750,000 from NINDS, $650,000 from NIDCD, $600,000 from NHLBI, and $250,000 from NIAAA. The expectation is that these combined resources would support the two cooperative agreement awards (one CC and one DOC), with the possibility that additional funds could become available from the existing co-sponsors or other NIH institutes depending on priorities and availability.
The project period for either component can be up to five years. For budgeting, the Coordinating Center application could request a first-year direct cost budget up to $760,000 per year. The Data and Operations Center application could request a first-year direct cost budget up to $12.4 million per year. A notable detail is that for the DOC budget, clinical site consortium indirect costs are included under the direct cost line as part of subcontracts, reflecting the reality that a major share of DOC spending would likely flow through to participating clinical sites and related operational partners.
Eligibility is intentionally narrow. This is a limited competition restricted to the grantees funded under the first PHACS funding announcement (RFA-HD-05-018), meaning it functions as a recompetition for renewal rather than an open call to new institutions. The FOA also notes eligible applicants include public and state-controlled institutions of higher education, but the limiting condition is the prior PHACS award status under the original RFA. For leadership, the FOA indicates that any individual with the skills, knowledge, and resources to carry out the work may serve as PD/PI, and it reiterates NIH's standard encouragement for applications involving individuals from underrepresented racial and ethnic groups and individuals with disabilities.
Administratively, the opportunity was posted September 1, 2009, with an original and current closing date of October 28, 2009, and an archive date of November 28, 2009. It does not require cost sharing or matching. The opportunity is categorized as discretionary and uses a cooperative agreement funding instrument, and it is associated with multiple CFDA numbers reflecting the cross-institute scope (including child health and development, infectious diseases, mental health, drug abuse, alcohol research, lung diseases, and deafness and communication disorders). The full announcement was hosted on the NIH grants site, with technical access issues directed to the NIH Office of Extramural Research webmaster.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Limited Competition for the Pediatric HIV/AIDS Cohort Study (U01)" and the Funding Opportunity Number is RFA-HD-09-006.
What type of grant mechanism is used?
This opportunity uses the NIH Cooperative Research Project Grant (U01) mechanism, which is a cooperative agreement rather than a standard research project grant.
What does a U01 cooperative agreement imply about NIH involvement?
A U01 cooperative agreement generally indicates substantial scientific and operational involvement by NIH program staff compared with a typical research project grant, reflecting a more collaborative model between awardees and NIH.
Which NIH institute issued the opportunity?
The opportunity was issued primarily by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Which other NIH institutes are involved as co-sponsors or funders?
Co-sponsorship and funding participation are described for multiple NIH institutes, including NIDA, NIAID, NIMH, NINDS, NIDCD, NHLBI, and NIAAA.
What is the overall goal of this funding opportunity?
The goal is to continue and sustain the observational cohorts created and followed during the first competitive funding cycle of the Pediatric HIV/AIDS Cohort Study (PHACS), rather than launching an entirely new cohort effort.
Is this funding intended to start a brand-new cohort study?
No. The emphasis is on maintaining continuity of follow-up and data collection in existing PHACS observational cohorts so that longer-term outcomes can be measured.
What are the main scientific questions PHACS is designed to address?
The scientific purpose centers on two long-running pediatric HIV research questions: (1) long-term safety of in utero exposure to combination antiretroviral therapy in HIV-exposed but uninfected children, and (2) how perinatal HIV infection and lifelong antiretroviral treatment interact to affect health and development from childhood through adolescence and into young adulthood.
Who are the primary participant groups of interest in this cohort effort?
PHACS focuses on children and adolescents affected by HIV and HIV treatment exposure, including HIV-exposed, uninfected children (exposed in utero but not infected) and children/adolescents living with perinatal HIV infection.
What outcomes or domains are specifically mentioned for long-term follow-up?
The announcement highlights the need to understand possible delayed or subtle effects on growth, neurodevelopment, metabolism, organ function, hearing, and other health outcomes related to in utero antiretroviral exposure, as well as developmental and behavioral health trajectories among youth living with perinatal HIV.
How many awards does NIH anticipate making under this FOA?
The FOA anticipates making two awards total.
What are the two components being funded?
The two anticipated awards correspond to: (1) the PHACS Coordinating Center (CC), and (2) the PHACS Data and Operations Center (DOC).
What is the role of the PHACS Coordinating Center (CC) as described?
The Coordinating Center would generally be responsible for overall coordination functions such as study governance support, protocol coordination across sites, communications, meeting logistics, and harmonization of cohort activities.
What is the role of the PHACS Data and Operations Center (DOC) as described?
The Data and Operations Center would typically provide the operational backbone for the cohort program, including data management, statistical support, operations, clinical site consortium management, and other large-scale infrastructure needed to keep the observational cohorts running smoothly and consistently.
What is the maximum project period?
The project period for either component can be up to five years.
What was the projected total funding level for FY 2010?
Funding for FY 2010 was projected at about $14.25 million in total costs (direct plus facilities and administrative costs), drawing from multiple institutes.
How much funding was each participating institute expected to contribute (as listed)?
The FOA lists intended commitments of approximately: $5.4 million (NICHD), $3.4 million (NIDA), $2.0 million (NIAID), $1.2 million (NIMH), $750,000 (NINDS), $650,000 (NIDCD), $600,000 (NHLBI), and $250,000 (NIAAA).
Could additional funds be added beyond the listed institute commitments?
The FOA notes there is a possibility that additional funds could become available from existing co-sponsors or other NIH institutes depending on priorities and availability.
What is the first-year direct cost budget limit for the Coordinating Center application?
The Coordinating Center application could request a first-year direct cost budget up to $760,000 per year.
What is the first-year direct cost budget limit for the Data and Operations Center application?
The Data and Operations Center application could request a first-year direct cost budget up to $12.4 million per year.
Does the DOC budget include clinical site consortium indirect costs?
Yes. A notable detail is that for the DOC budget, clinical site consortium indirect costs are included under the direct cost line as part of subcontracts.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
Is this an open competition for any institution?
No. Eligibility is intentionally narrow; this is a limited competition restricted to the grantees funded under the first PHACS funding announcement (RFA-HD-05-018).
Which prior funding announcement determines eligibility?
Eligibility is restricted to grantees funded under the original PHACS funding announcement RFA-HD-05-018.
What types of organizations are mentioned as eligible applicants?
The FOA notes eligible applicants include public and state-controlled institutions of higher education, but eligibility is limited by the requirement that applicants must have been PHACS grantees under the original RFA.
Who can serve as the PD/PI?
The FOA indicates that any individual with the skills, knowledge, and resources to carry out the work may serve as PD/PI.
Does the FOA encourage participation by underrepresented groups or individuals with disabilities?
Yes. It reiterates NIH's standard encouragement for applications involving individuals from underrepresented racial and ethnic groups and individuals with disabilities.
When was the opportunity posted, and what were the key dates?
The opportunity was posted on September 1, 2009. The original and current closing date was October 28, 2009, and the archive date was November 28, 2009.
What funding instrument category is this opportunity described as?
It is described as discretionary and uses a cooperative agreement funding instrument.
Does the FOA reference CFDA numbers?
Yes. It is associated with multiple CFDA numbers reflecting its cross-institute scope, including areas such as child health and development, infectious diseases, mental health, drug abuse, alcohol research, lung diseases, and deafness and communication disorders.
Where was the full announcement hosted, and where are technical access issues directed?
The full announcement was hosted on the NIH grants site, with technical access issues directed to the NIH Office of Extramural Research webmaster.
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