Opportunity Information: Apply for RFA CA 09 504

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Limited Competition Support for Human Specimen Banking in NCI Supported Clinical Trials Cooperative Group Banks (CGB) (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 93.395 Cancer Treatment Research 93.396 Cancer Biology Research.
  • This funding opportunity was created on Jul 24, 2009 and posted on Jul 24, 2009.
  • Applicants must submit their applications by Nov 17, 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 $8,750,000.00 to eligible and selected applicants.
  • Eligible applicants include: Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
  • Other Eligible Applicants include the following Regional Organizations.
Apply for RFA CA 09 504

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Opportunity Summary:

This Funding Opportunity Announcement (FOA), RFA-CA-09-504, is a limited competition renewal opportunity from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). It uses the U24 cooperative agreement mechanism, which typically means the awardee carries out the work with substantial NIH programmatic involvement rather than operating entirely independently. The core aim is to renew and continue support for the Cooperative Group Banks (CGBs), which are specialized specimen banking resources tied directly to NCI-supported cancer clinical trials.

The CGBs exist to collect, store, and distribute well-annotated human biospecimens from patients enrolled in NCI-funded Phase III and large Phase II clinical treatment trials. In practice, this means the banks are not just freezers and warehouses; they are long-term infrastructure programs responsible for receiving specimens from clinical trial sites, ensuring proper processing and storage, tracking chain-of-custody and quality parameters, and maintaining the link between each specimen and the clinical context in which it was obtained. A key emphasis in the FOA is annotation quality: specimens must be connected to high-quality clinical information, treatment details, and patient outcome data. That pairing of biospecimens with rigorous trial-grade data is what makes the CGB collections particularly valuable for translational research.

The scientific and public health rationale for continued support is centered on biomarker development and validation. By making trial-linked specimens broadly available to qualified investigators, the CGBs enable research that can identify and validate biomarkers used for cancer diagnosis (detecting or classifying disease), prognosis (predicting likely disease course), and prediction (forecasting how a patient is likely to respond to a specific therapy). Because the specimens come from patients treated on well-controlled clinical trials, investigators can study biomarkers in the context of standardized therapies and carefully measured endpoints, which strengthens the reliability of findings and helps move biomarkers toward clinical use.

From a program design standpoint, this FOA is focused on sustaining infrastructure and access rather than launching a brand-new specimen banking concept. It is explicitly a renewal solicitation for established Cooperative Group Banks, reflecting NCI interest in continuity: preserving collections, maintaining operating procedures, supporting distribution workflows, and ensuring ongoing availability of specimens and the associated datasets. The FOA also signals an expectation that these banks function as national resources, meaning they must be capable of serving the broader research community through transparent processes for requesting specimens and data, while protecting patient privacy and maintaining compliance with human subjects and data governance requirements typical of clinical trial-linked biospecimens.

Administratively, the opportunity is categorized as discretionary funding and falls under NIH health-related activity areas, with CFDA listings that include cancer detection and diagnosis research (93.394), cancer treatment research (93.395), and cancer biology research (93.396). No cost sharing or matching is required. The posted and created date for the announcement is July 24, 2009, with an original and current closing date of November 17, 2009, and an archive date of December 18, 2009. The estimated total funding amount is listed as $8,750,000, indicating a sizable investment intended to support multi-site, service-oriented infrastructure rather than a small single-lab research project.

Eligibility covers a range of organization types, including public and state-controlled institutions of higher education, private institutions of higher education, and nonprofit organizations (including those with 501(c)(3) status and certain nonprofits without 501(c)(3) status, other than institutions of higher education). The eligibility section also notes additional eligible applicants such as regional organizations, as further clarified in the full announcement. Overall, the eligible entities are those typically capable of managing complex, regulated biobanking operations with robust informatics, quality systems, and coordination functions tied to large national clinical trials.

For reference and full details, NIH provided an official link to the complete FOA at http://grants.nih.gov/grants/guide/rfa_files/RFA-CA-09-504.html, and included contact directions for technical issues accessing the announcement via the NIH Office of Extramural Research (OER) webmaster email.

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is a Funding Opportunity Announcement (FOA) from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), identified as RFA-CA-09-504. It is described as a limited competition renewal opportunity to continue support for Cooperative Group Banks (CGBs) associated with NCI-supported cancer clinical trials.

Who is sponsoring the FOA?

The FOA is sponsored by the National Cancer Institute (NCI) within the National Institutes of Health (NIH).

What does "limited competition renewal opportunity" mean in this FOA?

Based on the FOA description provided, this opportunity is intended to renew and continue existing support rather than launch a new, first-time specimen banking program. The emphasis is on continuity of established Cooperative Group Banks (CGBs).

What funding mechanism is used?

The FOA uses the U24 cooperative agreement mechanism. This typically means the awardee performs the work with substantial NIH programmatic involvement rather than operating entirely independently.

What are Cooperative Group Banks (CGBs)?

CGBs are specialized specimen banking resources tied directly to NCI-supported cancer clinical trials. They collect, store, and distribute well-annotated human biospecimens from patients enrolled in NCI-funded Phase III and large Phase II clinical treatment trials.

What kinds of clinical trials are the biospecimens associated with?

The CGBs focus on specimens from patients enrolled in NCI-funded Phase III and large Phase II clinical treatment trials.

What is the main purpose of renewing support for CGBs?

The central purpose is to sustain infrastructure and access: preserving collections, maintaining operating procedures, supporting distribution workflows, and ensuring ongoing availability of biospecimens and associated datasets to support research, particularly biomarker development and validation.

What activities do CGBs perform beyond storage?

They function as long-term infrastructure programs responsible for receiving specimens from clinical trial sites, ensuring proper processing and storage, tracking chain-of-custody and quality parameters, and maintaining the link between each specimen and the clinical context in which it was obtained.

Why is specimen annotation emphasized?

The FOA highlights that specimens must be connected to high-quality clinical information, treatment details, and patient outcome data. This trial-linked annotation is a key reason the collections are valuable for translational research and biomarker studies.

What makes CGB specimens particularly valuable for biomarker research?

The specimens come from well-controlled clinical trials where therapies are standardized and endpoints are carefully measured. This allows investigators to evaluate biomarkers in a rigorous clinical context, strengthening reliability and supporting movement toward clinical use.

What types of biomarker work does this program support?

The stated rationale centers on biomarker development and validation, including biomarkers for cancer diagnosis (detecting or classifying disease), prognosis (predicting disease course), and prediction (forecasting response to a specific therapy).

Who can access specimens and data supported by the CGBs?

The FOA indicates that specimens should be made broadly available to qualified investigators and that the banks are expected to function as national resources serving the broader research community.

How are specimen and data requests expected to be handled?

The FOA signals that banks should use transparent processes for requesting specimens and data, while also protecting patient privacy and maintaining compliance with applicable human subjects and data governance requirements for clinical trial-linked biospecimens.

What is the funding type/category?

The opportunity is categorized as discretionary funding and falls under NIH health-related activity areas.

Are cost sharing or matching funds required?

No. The provided information states that no cost sharing or matching is required.

What CFDA program areas are associated with this FOA?

The CFDA listings included are cancer detection and diagnosis research (93.394), cancer treatment research (93.395), and cancer biology research (93.396).

What is the estimated total funding amount?

The estimated total funding amount listed is $8,750,000.

When was the FOA posted/created?

The posted and created date is July 24, 2009.

What is the application closing date?

The original and current closing date is November 17, 2009.

When was the FOA archived?

The archive date is December 18, 2009.

What organizations are eligible to apply?

Eligibility includes public and state-controlled institutions of higher education, private institutions of higher education, and nonprofit organizations (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status, other than institutions of higher education). The eligibility section also notes additional eligible applicants such as regional organizations, as further clarified in the full announcement.

What kind of applicants does this FOA appear designed for?

Based on the description, eligible entities are those typically able to manage complex, regulated biobanking operations with robust informatics, quality systems, and coordination functions tied to large national clinical trials.

Where can applicants find the official FOA text?

The official FOA is available at: http://grants.nih.gov/grants/guide/rfa_files/RFA-CA-09-504.html

Who should be contacted for technical issues accessing the FOA?

For technical issues accessing the announcement, the FOA includes contact directions via the NIH Office of Extramural Research (OER) webmaster email.

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