Opportunity Information: Apply for RFA CA 19 059
The grant opportunity titled "Limited Competition: Pediatric Brain Tumor Consortium (UM1 Clinical Trials Required)" (Funding Opportunity Number RFA-CA-19-059) is a National Institutes of Health (NIH) funding announcement designed to continue federal support for the Pediatric Brain Tumor Consortium (PBTC). It uses a cooperative agreement mechanism (UM1), which typically means NIH will have substantial involvement in the direction, oversight, and coordination of the funded activities, reflecting the complexity and high-stakes nature of running a multi-site clinical trials consortium. The activity area is health, and it falls under CFDA number 93.395.
This is a limited competition announcement, meaning it is not open to the broader research community. It explicitly solicits a single application from the current PBTC awardee, with an expectation of making only one award. Eligible applicants are listed as public and state-controlled institutions of higher education, consistent with the consortium-based infrastructure and academic medical center leadership usually needed to conduct pediatric oncology trials. The award ceiling is $3,300,000, indicating the maximum anticipated funding level for the award under this announcement.
Programmatically, the FOA exists to maintain and strengthen the PBTC as a dedicated early-phase clinical trials organization focused on pediatric primary brain tumors. The PBTCs central purpose is to move promising, innovative therapies from laboratory and preclinical development into early phase testing in children, where new treatments can be evaluated for safety, dosing, biological activity, and early signals of effectiveness. The rationale for sustaining this consortium is grounded in the ongoing clinical reality that several pediatric brain tumors still have high mortality rates, including diffuse intrinsic pontine gliomas (DIPG), malignant supratentorial gliomas, and biologically high-risk forms of medulloblastoma and ependymoma. At the same time, for children who do survive with current standards of care, the announcement emphasizes that many experience significant long-term functional impairments, underscoring the need not only for better survival outcomes but also for treatments that reduce toxicity and preserve neurodevelopment and quality of life.
Within the NIHs pediatric brain tumor research portfolio, the PBTC is described as filling a distinct niche because of its ability to translate multiple innovative therapies into early clinical testing in a coordinated, efficient way. In practice, that niche typically involves the infrastructure and expertise needed for multi-institutional trial design and execution, centralized operations, consistent clinical and regulatory approaches, and the ability to rapidly open and conduct trials across participating sites. The "clinical trials required" designation signals that the funded work is expected to include clinical trials as a core deliverable rather than being limited to observational studies or preparatory research.
Key administrative details provided include a creation date of September 23, 2019, and an original closing date of November 13, 2019, indicating the historical posting and submission window for this specific continuation competition. Overall, the opportunity is best understood as a targeted continuation award meant to sustain a nationally significant pediatric neuro-oncology clinical trials consortium, with the explicit goal of accelerating early-phase testing of new therapies to improve outcomes and lessen long-term harm for children with primary brain tumors.Apply for RFA CA 19 059
- The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: Pediatric Brain Tumor Consortium (UM1 Clinical Trials Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
- This funding opportunity was created on Sep 23, 2019.
- Applicants must submit their applications by Nov 13, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $3,300,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education.
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Frequently Asked Questions (FAQs)
1) What is the name of this grant opportunity?
The opportunity is titled "Limited Competition: Pediatric Brain Tumor Consortium (UM1 Clinical Trials Required)."
2) What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-CA-19-059.
3) Which federal agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding announcement.
4) What is the funding mechanism used for this award?
The award uses a cooperative agreement mechanism (UM1). This typically means NIH will have substantial involvement in the direction, oversight, and coordination of the funded activities, reflecting the complexity of operating a multi-site clinical trials consortium.
5) Is this an open competition?
No. This is a limited competition and is not open to the broader research community.
6) Who is allowed to apply under this limited competition?
The announcement explicitly solicits a single application from the current Pediatric Brain Tumor Consortium (PBTC) awardee.
7) How many awards does NIH expect to make?
Only one award is expected under this announcement.
8) What types of institutions are listed as eligible applicants?
Eligible applicants are listed as public and state-controlled institutions of higher education.
9) What is the activity area or primary field of this funding opportunity?
The activity area is health, focused specifically on pediatric primary brain tumors and early-phase clinical trials infrastructure and execution.
10) What is the CFDA number associated with this opportunity?
The CFDA number is 93.395.
11) What is the purpose of this funding opportunity?
The purpose is to continue federal support for the Pediatric Brain Tumor Consortium (PBTC) and to maintain and strengthen it as a dedicated early-phase clinical trials organization focused on pediatric primary brain tumors.
12) What is the Pediatric Brain Tumor Consortium (PBTC) expected to do with this support?
The PBTC is expected to move promising, innovative therapies from laboratory and preclinical development into early-phase testing in children, where treatments can be evaluated for safety, dosing, biological activity, and early signals of effectiveness.
13) Are clinical trials required under this opportunity?
Yes. The funding announcement includes a "clinical trials required" designation, meaning clinical trials are expected to be a core deliverable of the funded work.
14) What kind of clinical trials does this consortium focus on?
The PBTC is described as an early-phase clinical trials organization. Early-phase trials typically concentrate on assessing safety, dosing, biological activity, and initial indications of effectiveness in pediatric patients.
15) Why is NIH continuing support for the PBTC?
The rationale is tied to ongoing unmet clinical needs in pediatric neuro-oncology. Several pediatric brain tumors still have high mortality rates, and many survivors experience significant long-term functional impairments. The consortium is intended to accelerate testing of new therapies that improve outcomes and reduce long-term harm.
16) Which pediatric brain tumors are specifically highlighted as having high mortality or high risk?
The announcement highlights diffuse intrinsic pontine gliomas (DIPG), malignant supratentorial gliomas, and biologically high-risk forms of medulloblastoma and ependymoma.
17) Beyond survival, what outcomes does the announcement emphasize?
It emphasizes reducing toxicity and preserving neurodevelopment and quality of life, reflecting concerns about long-term functional impairments among children who survive with current standards of care.
18) What niche does the PBTC fill within NIH's pediatric brain tumor research portfolio?
The PBTC is described as filling a distinct niche by translating multiple innovative therapies into early clinical testing in a coordinated and efficient way.
19) What capabilities are implied by this consortium "niche"?
The description points to infrastructure and expertise for multi-institutional trial design and execution, centralized operations, consistent clinical and regulatory approaches, and the ability to rapidly open and conduct trials across participating sites.
20) What is the award ceiling (maximum anticipated funding level)?
The award ceiling is $3,300,000.
21) Does the information provided specify the exact budget period or project duration?
No. The provided details identify an award ceiling but do not specify a budget period or project duration.
22) What are the key dates mentioned for this opportunity?
A creation date of September 23, 2019, and an original closing date of November 13, 2019 are provided.
23) Is this opportunity best viewed as a new program or a continuation?
It is best understood as a targeted continuation award intended to sustain a nationally significant pediatric neuro-oncology clinical trials consortium.
24) Does the opportunity suggest NIH will play an active role after award?
Yes. Because the mechanism is a UM1 cooperative agreement, NIH is expected to have substantial involvement in the direction, oversight, and coordination of the funded activities.
25) What is the overall goal of the PBTC according to the announcement?
The overall goal is to accelerate early-phase testing of new therapies for children with primary brain tumors, aiming to improve outcomes and lessen long-term harm.
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