Opportunity Information: Apply for RFA CA 14 501
Apply for RFA CA 14 501
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Limited Competition Biospecimen Banks to Support NCI Clinical Trials Network (NCTN) (U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research.
- This funding opportunity was created on Jun 5, 2014 and posted on Jun 5, 2014.
- Applicants must submit their applications by Aug 15, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $11,750,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $11,750,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Eligibility is limited to an institution/entity that is operating the physical infrastructure of one or more existing Group Banks of human specimens from Phase II and III cancer clinical treatment trials funded under RFA CA 09 504 (irrespective of whether the actual award under RFA CA 09 504 was made to this institution/entity or to another institution/entity under the former NCI sponsored Clinical Trials Cooperative Group Program structure). The eligible institutions may configure themselves at their discretion in terms of location of the biospecimen banking infrastructure (maintaining current or moving to a new location) and/or the selection of the institution/entity submitting the application (which can also be a foundation if it is a recipient of the NCTN Operations Center award under RFA CA 12 010) for one of the NCTN Groups, as long as a group of institutions applying together is affiliated for biospecimen banking with one and only one NCTN Group funded under RFA CA 12 010. Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NIH, through the National Cancer Institute (NCI), offered this limited-competition cooperative agreement (U24) to support the National Clinical Trials Network (NCTN) by funding a small number of Biospecimen Banks. The core purpose of the opportunity was to ensure that patients enrolled in NCI-supported cancer treatment trials have their collected biospecimens handled through modern, reliable, and well-coordinated banking operations. In practical terms, these banks were expected to serve as the backbone infrastructure that collects, processes, stores, tracks, and distributes human cancer specimens tied to NCI Phase III and large Phase II clinical trials, so researchers can use those materials to answer important questions about cancer biology and treatment response.
A central emphasis of the FOA is that specimens must be "well annotated" and connected to high-quality clinical data. That means the value of the bank is not only in physically storing tissue, blood, or other specimen types, but in maintaining accurate, up-to-date inventory systems and ensuring each specimen can be linked to key clinical information such as treatment details and patient outcomes. This linkage is what allows qualified investigators to perform rigorous biomarker discovery and validation work, including biomarkers used for cancer diagnosis, prognosis, and prediction of response to therapy. The announcement makes clear that the biospecimen banks are intended to function as a resource for the broader research community, distributing specimens to qualified investigators under controlled, quality-focused processes.
Operationally, the banks were expected to work closely with NCTN Groups and with the Groups' Statistical and Data Management Centers. This collaboration requirement highlights that the biospecimen workflow is tightly coupled to trial operations and data systems: specimen acquisition depends on trial protocols and site compliance, and specimen annotation depends on clean, harmonized clinical data capture. The FOA also specifies that one of the funded banks would have an added responsibility to provide biospecimen banking services for the NCI Experimental Therapeutics Clinical Trials Network (ETCTN), which focuses on Phase I and smaller Phase II trials. This requirement broadens the scope for at least one awardee, since ETCTN biospecimens come from earlier-phase studies that may have different collection patterns and translational research needs.
From a funding and administrative standpoint, this was a discretionary grant opportunity using a cooperative agreement mechanism (U24). A cooperative agreement generally implies substantial NIH/NCI program involvement compared to a standard research project grant, which aligns with the network-wide infrastructure role these banks play. The FOA anticipated up to five awards, with an estimated total funding amount of $11,750,000 and an award ceiling listed as $11,750,000. There was no cost sharing or matching requirement. The activity category is listed under Education/Health, and the CFDA number referenced is 93.394 (Cancer Detection and Diagnosis Research).
Eligibility was intentionally narrow because this was a "limited competition" announcement. Only U.S.-based institutions/entities that were already operating the physical infrastructure of one or more existing Group Banks of human specimens from Phase II and III cancer clinical treatment trials funded under a prior NCI cooperative group banking FOA (RFA-CA-09-504) were eligible. The FOA notes that eligibility applied regardless of whether the earlier award was technically made to the same institution or to a different institution under the former Cooperative Group Program structure, as long as the applicant entity is operating the physical banking infrastructure. Applicants were allowed flexibility in how they organized themselves, including whether the bank infrastructure remained in place or moved to a new location, and which affiliated entity submitted the application (including a foundation, if it held the NCTN Operations Center award under RFA-CA-12-010). However, a key constraint was that any group of institutions applying together had to be affiliated for biospecimen banking with one and only one NCTN Group funded under RFA-CA-12-010. Foreign institutions were not eligible, and foreign components of U.S. organizations were explicitly not allowed.
Key dates show this was posted June 5, 2014, with an original and current closing date of August 15, 2014, and an archive date of September 15, 2014, indicating the opportunity is no longer open. The official funding opportunity number is RFA-CA-14-501, and the full announcement was made available through the NIH Grants Guide. Contact support was provided via the NIH Office of Extramural Research (OER) webmaster addresses for technical access issues.
Overall, the opportunity was designed to ensure the NCTN (and, for one bank, the ETCTN) had dependable, standardized, and scalable biospecimen banking capacity. By tightly integrating specimen handling with clinical trial operations and high-quality clinical data, the program aimed to accelerate biomarker development and validation efforts that can improve cancer diagnosis and guide treatment decisions, while keeping biospecimen resources organized, current, and accessible to appropriately qualified researchers.
Frequently Asked Questions (FAQs)
What is this NIH/NCI funding opportunity about?
This was a limited-competition NIH opportunity from the National Cancer Institute (NCI) to fund a small number of Biospecimen Banks that support the National Clinical Trials Network (NCTN). The goal was to ensure biospecimens collected from patients enrolled in NCI-supported cancer treatment trials are handled through modern, reliable, and well-coordinated banking operations.
What is the primary purpose of the funded Biospecimen Banks?
The banks were intended to serve as core infrastructure that collects, processes, stores, tracks, and distributes human cancer biospecimens associated with NCI Phase III and large Phase II clinical trials. The overarching purpose was to make these well-managed specimens available for research that addresses key questions about cancer biology and treatment response.
What kinds of clinical trials are tied to these biospecimens?
The focus was on NCI-supported cancer treatment trials, specifically Phase III and large Phase II trials within the NCTN. In addition, at least one funded bank was expected to provide services for the NCI Experimental Therapeutics Clinical Trials Network (ETCTN), which includes Phase I and smaller Phase II trials.
What activities were the Biospecimen Banks expected to perform?
Based on the description, expected banking operations included collecting, processing, storing, tracking (inventory), and distributing human cancer specimens tied to qualifying NCI-supported clinical trials, using quality-focused and well-coordinated processes.
Why does the FOA emphasize "well annotated" specimens?
The funding announcement emphasizes that specimens must be well annotated and connected to high-quality clinical data. The value of the bank is not just in storage, but in maintaining accurate, up-to-date inventory systems and ensuring each specimen can be linked to key clinical information such as treatment details and patient outcomes.
What clinical information needs to be linked to each specimen?
The announcement specifically highlights linkage to clinical information such as treatment details and patient outcomes, supported by high-quality clinical data capture and harmonization.
How are these biospecimens intended to be used by researchers?
The banks were intended to support rigorous biomarker discovery and validation, including biomarkers used for cancer diagnosis, prognosis, and prediction of response to therapy, by providing appropriately annotated specimens linked to strong clinical data.
Are these Biospecimen Banks meant to serve only their own trial groups?
No. The announcement states the biospecimen banks are intended to function as a resource for the broader research community by distributing specimens to qualified investigators under controlled, quality-focused processes.
Who would the Biospecimen Banks work with operationally?
The banks were expected to work closely with NCTN Groups and with the Groups' Statistical and Data Management Centers. This reflects that specimen workflows depend on clinical trial protocols, collection compliance at sites, and clean/harmonized clinical data capture.
What is ETCTN, and how does it affect the scope of awards?
The NCI Experimental Therapeutics Clinical Trials Network (ETCTN) focuses on Phase I and smaller Phase II trials. The FOA specifies that one funded bank would have additional responsibility to provide biospecimen banking services for ETCTN, expanding that awardee's scope to include earlier-phase studies.
What mechanism did NIH use for this opportunity?
This opportunity used a cooperative agreement mechanism (U24). The description indicates this implies substantial NIH/NCI program involvement compared to a standard research project grant, consistent with the network-wide infrastructure role of the funded banks.
How many awards were anticipated?
The FOA anticipated up to five awards.
What was the estimated total funding amount?
The estimated total funding amount was $11,750,000.
What was the listed award ceiling?
The award ceiling was listed as $11,750,000.
Was cost sharing or matching required?
No. The opportunity explicitly stated there was no cost sharing or matching requirement.
What is the activity category and CFDA number referenced?
The activity category is listed under Education/Health. The CFDA number referenced is 93.394 (Cancer Detection and Diagnosis Research).
What does "limited competition" mean for eligibility here?
Eligibility was intentionally narrow. Only U.S.-based institutions/entities already operating the physical infrastructure of one or more existing Group Banks of human specimens from Phase II and III cancer clinical treatment trials funded under a prior NCI cooperative group banking FOA (RFA-CA-09-504) were eligible.
Which prior funding announcement is tied to eligibility?
The FOA ties eligibility to operating infrastructure originally funded under RFA-CA-09-504.
Did the applicant have to be the exact same institution that received the earlier award?
No. The FOA notes eligibility applied regardless of whether the earlier award was made to the same institution or to a different institution under the former Cooperative Group Program structure, as long as the applicant entity is operating the physical banking infrastructure.
Could the banking infrastructure be relocated and still be eligible?
Yes. The FOA allowed flexibility in how applicants organized themselves, including whether the bank infrastructure remained in place or moved to a new location, as long as the applicant entity is operating the physical banking infrastructure.
Who was allowed to submit the application (for example, could a foundation apply)?
The FOA allowed flexibility in which affiliated entity submitted the application, including a foundation, if it held the NCTN Operations Center award under RFA-CA-12-010.
If multiple institutions applied together, were there affiliation constraints?
Yes. Any group of institutions applying together had to be affiliated for biospecimen banking with one and only one NCTN Group funded under RFA-CA-12-010.
Were foreign institutions eligible to apply?
No. Foreign institutions were not eligible.
Are foreign components of U.S. organizations allowed?
No. The FOA explicitly stated that foreign components of U.S. organizations were not allowed.
What is the Funding Opportunity Announcement (FOA) number?
The official FOA number is RFA-CA-14-501.
When was this opportunity posted and when did it close?
The opportunity was posted on June 5, 2014. The original and current closing date was August 15, 2014.
Is this funding opportunity still open?
No. The archive date was September 15, 2014, indicating the opportunity is no longer open.
Where was the full announcement published?
The full announcement was made available through the NIH Grants Guide.
Who provided help for technical access issues related to the announcement?
Technical access support was provided via the NIH Office of Extramural Research (OER) webmaster addresses (as referenced in the opportunity information).
What was the overall program aim for NCTN (and ETCTN for one bank)?
The program was designed to ensure dependable, standardized, and scalable biospecimen banking capacity tightly integrated with clinical trial operations and high-quality clinical data, to accelerate biomarker development and validation that can improve cancer diagnosis and guide treatment decisions.
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