Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01) | RFA DK 16 512

Opportunity Information: Apply for RFA DK 16 512

This funding opportunity, titled "Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01)," is a National Institutes of Health (NIH) discretionary grant announcement designed to support the ongoing work of the Hepatitis B Research Network (HBRN) through its established clinical centers. The FOA is specifically aimed at continuing a coordinated, multi-center clinical research infrastructure that advances translational hepatitis B research, meaning studies that connect basic scientific discovery to real-world clinical applications. The overall scientific emphasis is on improving understanding of hepatitis B virus (HBV) disease mechanisms and progression, while also strengthening the evidence base for better treatment approaches and broader strategies for disease control.

The core purpose of the FOA is to sustain and extend research that clarifies HBV pathogenesis and natural history. In practical terms, this includes efforts to explain how HBV infection causes liver disease, what biological or clinical factors influence whether infection remains stable or progresses, and how patient outcomes differ across populations and clinical presentations. By supporting clinical centers within a network model, the initiative is positioned to enable consistent study protocols, robust patient recruitment and follow-up, high-quality data collection, and the ability to conduct research across multiple sites, which is often essential for understanding a disease with diverse clinical trajectories and varying prevalence among different demographic groups.

The award mechanism is a U01 cooperative agreement. This matters because a cooperative agreement is not a standard investigator-initiated grant where the funded institution operates largely independently; instead, it typically involves substantial scientific and/or programmatic involvement by NIH staff during the conduct of the project. In the context of a clinical research network, this structure generally supports coordinated governance, shared standards, collaborative protocol development, and centralized oversight to ensure the network functions as an integrated whole. The activity category is listed under health, and the relevant CFDA number is 93.847, which aligns with NIH programs supporting diabetes, digestive, and kidney diseases-related research areas, including viral hepatitis as administered through the appropriate NIH institute and program structures.

Eligibility is deliberately narrow because this is a limited competition focused on continuity. Only current HBRN awardees are eligible to apply, meaning the FOA is intended for existing network clinical centers rather than new entrants. The eligibility language also notes that faith-based or community-based organizations may be among eligible applicants, but this does not broaden the competition beyond current HBRN awardees; it mainly clarifies that organizational type is not a barrier as long as the applicant is an existing awardee meeting the FOA requirements. The FOA allows non-domestic (non-U.S.) entities (foreign institutions) to apply, which is notable given the global burden and epidemiology of hepatitis B. At the same time, it places important restrictions on foreign involvement: non-domestic components of U.S. organizations are not eligible to apply, and foreign components, as defined by the NIH Grants Policy Statement, are not allowed. In other words, a foreign institution can potentially be the applicant if it is an eligible current awardee, but U.S. institutions cannot propose foreign components under this FOA, and the typical NIH concept of a "foreign component" is explicitly prohibited.

From the administrative details provided, the FOA number is RFA-DK-16-512, and the original closing date for applications was December 19, 2016, with a creation date of August 18, 2016. The listing identifies the instrument as a cooperative agreement and the opportunity category as discretionary. The award ceiling and expected number of awards are not specified in the provided excerpt, which suggests applicants would need to consult the full FOA text for budget limits, project period expectations, and network-specific requirements around scope, milestones, data sharing, governance, and performance.

Overall, this opportunity is best understood as a continuation mechanism meant to preserve and enhance an existing NIH-supported clinical research network focused on hepatitis B. Its priorities center on translational research that can explain disease behavior over time, identify clinically meaningful mechanisms and markers, and support development or refinement of treatment and control strategies, while maintaining a structured, NIH-partnered cooperative framework across participating clinical centers.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2016-08-18.
• Applicants must submit their applications by 2016-12-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Others.

Apply for RFA DK 16 512

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