The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratories (U24 Clinical Trials Not Allowed) | RFA CA 19 008

Opportunity Information: Apply for RFA CA 19 008

The National Cancer Institute (NCI), part of the National Institutes of Health, released this funding opportunity (RFA-CA-19-008) to establish Pharmacokinetic Resource Laboratories that serve the Experimental Therapeutics Clinical Trials Network (ETCTN). The basic idea is to fund specialized labs that can reliably handle the real-world logistics and scientific work needed to understand how NCI investigational cancer drugs behave in people during early phase ETCTN trials. These awards use a U24 cooperative agreement mechanism, meaning the labs are expected to work closely with NCI program staff and align with network priorities rather than operating as fully independent investigator-initiated projects. Despite being tied to clinical trial activity, the notice is labeled "Clinical Trials Not Allowed" for the U24 itself, reflecting that the award supports pharmacokinetic resource functions and analyses for ETCTN trials rather than running a clinical trial as the primary purpose of the grant.

The core mission of the PK Resource Laboratories is to advance the clinical development of NCI Investigational New Drug (IND) agents by generating a comprehensive understanding of pharmacokinetic behavior across ETCTN protocols. In practice, that means the funded labs must be able to plan and coordinate specimen collection and then perform the downstream analyses that translate blood or other biospecimen measurements into pharmacokinetic endpoints. The FOA highlights several specific analytic domains the labs are expected to cover: standard pharmacokinetic endpoints (such as concentration-time profiles that support exposure metrics), drug-drug interaction assessments, cytochrome P450 (CYP) interaction work, and evaluation of food effects. All of these are especially important in early oncology drug development, where patients often take multiple medications, metabolism and transport pathways can create clinically meaningful interactions, and dosing instructions can change based on whether a drug should be taken with food or on an empty stomach.

This opportunity is positioned as an ETCTN-wide service capability rather than a small, single-study laboratory effort. Applicants are expected to be multidisciplinary groups with the capacity to conduct all pharmacokinetic studies supporting ETCTN early phase clinical trials that are filed to IND applications managed within NCI's Division of Cancer Treatment and Diagnosis (DCTD), specifically the Cancer Therapy Evaluation Program (CTEP). The language strongly signals that NCI wants consistent, high-quality pharmacokinetic operations across the network so that studies are comparable, data are reliable, and development decisions for NCI-IND agents can be made with confidence. Because the work spans specimen handling, assay development and validation, data analysis, and operational coordination with clinical sites, the FOA also emphasizes staffing depth, calling out the need for physicians, clinical pharmacologists, nurses, and scientists who understand pharmacokinetic studies in early drug development and translational research settings.

In terms of eligibility, the FOA is open to a wide range of domestic organizations. Eligible applicants include various levels of government (state, county, city/township, and special district governments), public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments, tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, and both nonprofit and for-profit organizations (including small businesses). The announcement also explicitly mentions categories such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, along with faith-based or community-based organizations and U.S. territories or possessions. At the same time, it draws a firm boundary around foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

Administratively, the grant is listed under CFDA 93.395 and categorized under education and health. The original closing date shown is May 22, 2019, with a creation date of January 10, 2019. The listed award ceiling is $320,000, and the funding instrument is a cooperative agreement, reinforcing the expectation of substantial coordination with NCI/CTEP and the ETCTN infrastructure. Overall, the opportunity is best understood as NCI building a centralized, expert pharmacokinetic backbone for ETCTN early phase trials, so that every supported study has access to consistent specimen collection coordination, validated analytic methods, and rigorous interpretation of pharmacokinetic and interaction data for NCI-IND oncology agents.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratories (U24 Clinical Trials Not Allowed)" 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 2019-01-10.
• Applicants must submit their applications by 2019-05-22. (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 $320,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA CA 19 008

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