NIAID Just Put the Immune Tolerance Network Up for Recompetition: One Award, $27M in FY2028, Seven Years, and a Direct-Cost Cap 10% Below What the Network Spends Today

Most NIH funding announcements fund projects. A handful fund the infrastructure that a whole subfield of clinical research runs on, and those come up for competition about once every seven years.

On October 20, 2026, the National Institute of Allergy and Infectious Diseases posted one of the second kind. RFA-AI-28-005, "Immune Tolerance Network (UM1 Clinical Trial Required)", reissues RFA-AI-19-068 and recompetes the entire Immune Tolerance Network (ITN). The ITN is NIAID's clinical trials consortium for therapies that retrain the immune system instead of suppressing it, across allergy and asthma, autoimmune disease, and transplantation.

There will be one award. NIAID intends to commit $27 million in FY2028 to it. Applications open December 29, 2026 and are due January 29, 2027.

The money matters less than the structure. Whoever wins takes over a live portfolio. NIAID's own budgeting instructions tell applicants to assume that at the time of award, "approximately 20 clinical trials and associated mechanistic studies involving an estimated 200 sub-agreements will be ongoing." That makes this a bid to take over and run an existing operation, and the strategy follows from that.

The numbers, precisely

One discrepancy to note: the Grants.gov synopsis lists estimated total program funding of $21,986,000. The NOFO text says $27M in FY2028. For budgeting, the NOFO governs, and the direct-cost ceiling of $23M per year is the binding constraint either way. Confirm with the scientific contact (ITN_UM1@mail.nih.gov) before final budget build.

What the network costs today, and why the ceiling is a cut

The current ITN award is UM1AI109565, held by the Benaroya Research Institute at Virginia Mason in Seattle. It started in February 2014 under Gerald Nepom and was renewed in 2021. Mark S. Anderson and Jane Hoyt Buckner are now the contact and multiple PIs. NIH RePORTER shows the project period ending January 31, 2028, one day before the new award's earliest start date. NIAID has set this competition up as a handoff with no gap.

Here is what that award has looked like in recent years, from RePORTER:

FY2026 also carried five administrative supplements totaling about $6.29M, so the network's all-in FY2026 federal obligation was roughly $34.8M.

Against that baseline, the new NOFO's $23M direct-cost ceiling is about 10% below the FY2026 base award's $25.56M in direct costs. The $27M FY2028 commitment is about 5% below the FY2026 base total. NIAID has not said it is shrinking the network. But it is asking the next awardee to run at least four new trials a year, plus the inherited portfolio of about 20, on a smaller direct budget than the network has now.

The indirect line is low because most ITN spending flows through sub-agreements, and under the standard modified total direct cost base only the first $25,000 of each subaward draws F&A. That pattern will hold for any applicant. Do not build a budget that assumes a 50%-plus negotiated rate applies to the bulk of the $23M.

What the network has to do

The NOFO is explicit that an application must cover all three clinical areas. An application that skips one is non-responsive and will not be reviewed.

• Allergic diseases and asthma: interventions that prevent onset or induce durable remission, safer and more effective allergen immunotherapy, and mechanistic studies of how tolerance develops or is lost naturally.
• Autoimmune diseases: antigen-specific therapies; co-stimulatory blockade, cytokine modulation, and T regulatory cell approaches; and immune "reset" strategies built on cell depletion or replacement.
• Transplantation: donor-specific tolerance and long-term graft survival, including cell therapies and novel biologics; reducing the toxicity of chronic immunosuppression (nephrotoxicity, malignancy, allosensitization); and biomarkers that predict who can be safely weaned.

The NOFO frames the transplant problem with numbers. It cites more than 49,000 US transplants in 2025, more than 81,000 waitlist additions, more than 100,000 candidates still waiting at year-end, and 10-year graft survival ranging from under 30% for lung to 60-70% for kidney.

Four functional areas organize the work, and the Research Strategy has a page limit for each:

That is 114 pages of Research Strategy, against a standard R01's 12. Leadership gets as much room as the core lab. In practice reviewers will read Subsection B as the application's thesis: governance, committee structure, how trials are selected and killed, fiscal management, site management, and how performance is measured.

What NIAID provides, and what that means for your design

NIAID acts as the regulatory sponsor for most ITN trials and holds the INDs and IDEs. It also funds a ring of contract resources the network plugs into. These include three statistical and clinical coordinating centers (one each for allergy/asthma, autoimmune, and transplantation), a Clinical Data and Safety Management Center, a site monitoring contract, a Clinical Products Center, a Regulatory Management Center, and the ImmPort data portal, where all ITN data must ultimately be shared.

The NOFO asks leadership to explain how it will "integrate NIAID-provided resources into the overall organizational structure and to minimize duplication of effort." If an application budgets in-house statistics, regulatory affairs, and data management that NIAID already pays for, reviewers will see it as wasting the smaller budget. The efficient design treats the NIAID contracts as fixed and spends the $23M on trial design, site support, mechanistic science, and the biorepository.

The fine print that will trip people up

One application per institution. This is counted by UEI or NIH IPF number. At large academic medical centers, transplant, rheumatology, and allergy groups may each think they should lead. Your sponsored-programs office needs to settle that internally by early December, because the system opens December 29.

Seven years, exactly. The project period "must be 7 years." No one-time automatic extension is granted, and the NOFO says a 7-year grant does not qualify for a no-cost extension. All funds must be spent within the period.

No foreign subawards. Foreign institutions cannot apply, and under current NIH policy applications with foreign subawards are noncompliant. Foreign components, consultants, and unique foreign-sourced supplies are still allowed. For a network that has historically run international trial sites, this is a real design constraint. Any non-US site has to be structured as a foreign component without a subaward, or dropped.

PI effort floors. A single PD/PI must commit at least 3.6 person-months a year. With multiple PIs, each must commit at least 1.8.

Meetings are budgeted for you. Include a kick-off meeting in the Bethesda area within six months of award and two Steering meetings a year at locations NIAID picks.

Delayed-onset study record. Every applicant must file a "Multiple Delayed-Onset Studies" record and explain the concept-then-protocol approval pipeline. Future protocols do not exist yet, and the application is judged on the process that will produce them.

Do not name future committee members. The NOFO says not to name potential committee members unless they are already key personnel. Listing prominent outside names as "planned Steering Committee members" is a compliance error, not a strength.

The newer award terms apply. The NoA will include the 2 CFR 200.340(a)(4) termination language ("no longer effectuates the program goals or agency priorities"), the HHS cybersecurity plan requirements with 48-hour incident reporting, and a newer term requiring annual reporting of standardized clinical trial activation and enrollment milestone dates. NIH will calculate startup and enrollment interval metrics from those dates. An ITN applicant should treat that last term as a scored opportunity. Show that you already track site activation intervals and can report them.

Incumbent vs. challenger: how the two cases differ

Renewal applications are allowed, and reviewers "will consider the progress made in the last funding period." The Benaroya-led team will be judged on its record. That record includes a large trial portfolio and the ITN's past results. The best known is the LEAP peanut allergy trial, which shaped the 2017 NIAID guidance on early peanut introduction.

A challenger has a harder version of the same task. Reviewers will expect a credible plan to take over about 20 trials in flight and about 200 sub-agreements without disrupting enrollment, the biorepository, or sIRB oversight. The NOFO requires leadership to manage "communication between the Network and the single Institutional Review Board" and to lead "all Network personnel, consultants and research support services necessary for the continuation and completion" of ongoing work. A challenger application without a detailed transition plan will not score. That plan should cover months 1-6, the sub-agreement novation sequence, biorepository custody, and data continuity through ImmPort.

For everyone else, the realistic path into this money is as a clinical site or a core-lab partner, not as the prime. Roughly 200 sub-agreements means most of the budget flows outward to participating centers. Investigators with tolerance-relevant trial concepts in any of the three areas, and the enrollment numbers to back them, should be talking to prospective lead teams now. Do the same once the award is made, because the network's concept-review pipeline is how new trials get in during the seven years.

How to position an application

1. Lead with operations. The scored criteria are standard UM1 criteria, but the clinical-trial-specific questions ask whether the leadership can "organize, manage and implement" multicenter trials and "meet milestones and timelines." The 30-page Leadership and Clinical Operations sections are where the award is won.
2. Show the efficiency math. Use the four-way budget breakout the NOFO demands (Leadership, Clinical Operations, Core Laboratory, Bioinformatics). Explain how four-plus new trials a year fit under $23M in direct costs, and lean on NIAID's coordinating centers rather than duplicating them.
3. Balance the three areas. The budgeting instruction says to assume "a balance of new clinical and associated mechanistic studies across the three disease areas." An application that is plainly a transplant network with allergy and autoimmunity attached will lose ground.
4. Make mechanistic science pay for itself. The Core Laboratory and Bioinformatics sections should show how samples from inherited trials become new mechanistic findings and new trial concepts. A biorepository that only stores samples is not enough.
5. Build the metrics now. Define your network performance metrics in the application: productivity, quality, trial startup time, enrollment against target, and cost per participant. Make them consistent with the activation and enrollment data NIH will collect after award.
6. Settle the institution question in November. With one application per institution, a strong team can lose its slot to an internal rival without ever reaching peer review.

The short version

RFA-AI-28-005 is the once-every-seven-years competition for NIAID's flagship immune tolerance trials network. It is one award of $27M in FY2028, capped at $23M a year in direct costs (about 10% below what the network spends today), over a mandatory seven-year period from February 2028. The deadline is January 29, 2027, and only one application is allowed per institution. The incumbent is the Benaroya Research Institute, whose current award ends the day before the new one can start. Challengers need a credible takeover plan for roughly 20 live trials and 200 sub-agreements. Most investigators will get access to this money as network sites and partners, not as the lead.

Sources: the RFA-AI-28-005 listing on Grants.gov and the NIH RePORTER record for UM1AI109565.

If you are building a site-partner pitch to a prospective lead team, or tracking the companion NIAID infrastructure competitions posted the same week such as the microphysiological systems centers under RFA-AI-28-012, Granted can help turn a trial concept into a network-ready proposal.