RFA-AI-27-012: Coccidioidomycosis Collaborative Research Centers (P01 Clinical Trial Not Allowed)

RFA-AI-27-012: Coccidioidomycosis Collaborative Research Centers (P01 Clinical Trial Not Allowed)

The Coccidioidomycosis Collaborative Research Centers (CCRC) announcement is a 2026 NIH funding push for teams that can build coordinated biomedical programs around Valley fever, formally known as coccidioidomycosis. Unlike single-project grants, this opportunity funds a center-like structure under NIH activity code P01 (research program projects) and explicitly bans clinical-trial projects, making it a high-coordination R&D call rather than a treatment-testing program.

If you are deciding quickly whether this is relevant, use this filter:

• You need at least one strong institutional base in the United States,
• You can assemble a multi-project structure with shared administration and shared resources,
• You can move ahead during the 2026 application cycle with a likely start in 2027.

This NOFO is active for applications received by 2026-07-09 and is designed as a multi-component, center-style submission. It can be a strong strategic fit for groups already running coccidioidomycosis research in endemic regions and wanting a mechanism to scale cross-project coordination and infrastructure support across disciplines.

Key details

Why this opportunity exists and why it is timed for 2026/2027

The announcement text identifies Valley fever as a rising public health burden in arid regions and emphasizes that a vaccine remains a long-range goal requiring stronger translational infrastructure than isolated pilot projects can usually provide. NIAID frames CCRC as a mechanism to connect discovery, patient-derived evidence, translational development, and shared support services under one multi-project umbrella.

Two timing points matter:

1. The posted/earliest submission schedule indicates this is a near-term 2026 window with a formal due date in July and an earliest start not immediate in the same calendar year.
2. The planning horizon in the grant lifecycle spans into 2027, with peer review and award review leading to a projected start around late 2026 and a program-year period in FY 2027.

For teams planning a 2026 pipeline, this is often the first meaningful chance to position a mature preclinical/clinical-translational research cluster for a vaccine direction before broader opportunities tighten. If your organization is waiting for smaller project calls and only then deciding on collaboration, this NOFO is likely not ideal. If your team is already running shared assays, regional patient cohorts, and at least two robust research tracks, it is often the right mechanism.

Fit and scope: what the opportunity is explicitly for

The NOFO gives a clear picture of what a valid CCRC should do:

• Establish a collaborative, multidisciplinary center focused on coccidioidomycosis.
• Align research themes with the NIAID Valley fever vaccine strategic planning framework.
• Include integrated projects and cores that produce stronger impact than standalone grant units.
• Support translational and clinical research components while avoiding direct clinical trials.

The call defines the preferred content areas as:

• Vaccine and immunomodulatory target discovery.
• Immune protection correlates and mechanism-focused validation.
• Diagnostic development relevant to vaccine testing.
• Coordination between basic, clinical, and translational teams.

This is not a grant for single-lab work disconnected from a broader center structure. The center must provide shared governance and shared outputs that make collaboration visible in the application, not implied in narrative.

Program architecture (what the full application must include)

Applicants must build a structure with multiple named components. The NOFO explicitly requires:

• An Administrative Core (required).
• 2–4 Research Projects (required minimum 2).
• Optional Core(s), up to 2.
• A Development and Research Program (DRP) mechanism with up to two DRP awards per year.

In plain language, this is a modular architecture: the Administrative Core coordinates policy, reporting, staffing, and execution governance; Research Projects provide scientific substance across complementary angles; and optional cores provide shared technical functions when justified.

Required ingredients to avoid a compliance failure

The NOFO is strict on a few points:

• At least one project must include clinical research using Valley fever patient samples from endemic areas.
• A nonresponsive example includes any project focus not centered on coccidioidomycosis biology.
• Any external advisory committee is optional, not mandatory, but if included it must be described clearly.
• The application’s components must map to NIH’s Multi-Project (M) format and use allowed forms.

The strongest applications in this structure are usually those where each component has a reason for existence and a deliverable tied to the same umbrella scientific question.

Eligibility and institutional fit

The NOFO lists a broad domestic applicant set:

• Public and private higher education institutions.
• Nonprofits (501(c)(3) and non-501(c)(3)).
• Small businesses and for-profit organizations.
• State, county, city, and special district governments.
• Qualified federal entities and some additional domestic organizations.

But it also includes important boundary conditions:

• Foreign organizations are not eligible to apply.
• Foreign components of U.S. institutions are not eligible as applicants.
• Institutional collaborations that include foreign subawards are excluded under this NOFO.
• Only one application per institution is allowed.

You should read this as a “domestic organizational host” requirement paired with high internal governance expectations. Even if your science partners include international collaborators, you cannot run foreign subawards in this mechanism. That can remove strong otherwise-credible teams if not handled early.

PI and organization readiness requirements are operational:

• PD(s)/PI must be properly registered in eRA Commons.
• The applicant organization must be current in SAM and ORCID-linked where required.
• The submission can be blocked by registration delays; NIH guidance warns that registration can take weeks.

If your institution’s grants office has not completed system setup, that is the highest-probability blocker and should be resolved first.

Eligibility and timeline alignment for 2026/2027 applicants

A practical interpretation of the dates:

• May 4, 2026 posted date: the formal opportunity is open.
• June 9, 2026 open/submission date: earliest start for collection and compliance workflow.
• July 9, 2026 deadline: all forms and components must be complete.
• July 10, 2026 expiry: not much time after deadline for late procedural recovery.
• FY 2027 funding intent and early 2027 peer-review/advisory pipeline implied by the table.

These markers are useful for scheduling:

1. If your team is still building a full center concept in late June, the NOFO is not a fit unless your submission is ready by early July.
2. If your team is already mid-cycle with coccidioidomycosis research, this is often a useful “upgrade” channel that can carry a stronger multi-core strategy.

Application format and submission mechanics

This is an NIH-specific process with heavy compliance dependency:

• You submit through NIH ASSIST or an institutional system-to-system route that submits via Grants.gov and tracks in eRA Commons.
• NIH Multi-Project instructions apply, with explicit component-level requirements.
• For many sections, page limits are fixed and failure to follow them can affect readiness for peer review.

At minimum, you should expect to prepare each required component as a coherent packet, including:

• Overall component package.
• Administrative core package.
• Required Research Projects packages.
• Optional Core(s), only if justified and aligned with at least two projects.

For P01 planning, teams commonly underestimate internal workload in the visual and governance parts of the application. The NOFO requires strong documentation of how projects interact and how resources flow across project and core elements.

Page and component details to plan for

The NOFO indicates required components and page limits:

• Overall: required one package.
• Administrative Core: required one package.
• Research Projects: minimum two, maximum four.
• Optional Cores: up to two.

Treat this as a hard structural requirement. If your proposal currently reads like one central project with “add-on” experiments, this is not enough. You need explicit integration logic in the center design.

Required evidence and documentation

Applicants should assemble ahead of time:

• DMS plan (required when generating NIH data).
• Human subjects documentation for any clinical research activity, including non-trial clinical work where applicable.
• Biosketches that demonstrate integrated team leadership, especially PD/PI coordination capacity.
• Facilities and resources narrative tying the center to endemic-region cohorts and relevant sample access.
• Facilities and patient sample strategy that supports the translation axis.

The NOFO also flags that non-trial clinical research can be included, but no clinical trials may be proposed.

Who this opportunity is best for

This opportunity is a strong fit for institutions that can show:

• Existing coccidioidomycosis work across at least two linked disciplines.
• Clear institutional commitment to support center administration for five years.
• Ability to integrate basic discovery with translational testing and operational governance.
• Access to Valley fever clinical populations and specimen channels in endemic regions.
• Early-career development strategy through DRP awards.

The DRP component is strategically important. It is designed to support up to two awards per year and focus on early-career investigators. That means you can structure the center as a training-generating engine, not just a high-budget operational unit.

Good signs of strategic fit:

• You already have a strong senior leadership team and a junior investigator pipeline.
• You can produce explicit cross-project milestones.
• You have realistic assumptions about cost-sharing and center operations.
• You can provide evidence-sharing structures (reagents, analytical pipelines, tissue/immune assay resources, computational interfaces).

Poor fit:

• Only one principal lab with no broad collaborations.
• No realistic budget to support administration and shared resources.
• A concept rooted only in HIV/AIDS, SIV, or other non-coccidioid fungal diseases.
• Inability to produce measurable clinical-research components from endemic settings.

Review logic: what reviewers tend to score and what they ignore

Scientific review is standard NIH model: significance, innovation, approach, investigators, and environment apply across project-level and overall center-level elements. In a multi-project center, additional emphasis falls on:

• Whether the administrative design actually enables integration.
• Whether cores truly support multiple projects and reduce duplication.
• Whether the budget is justified and realistic for multi-year program output.
• Whether proposed collaborations are feasible and governance is robust.
• Whether patient-sample use and translational relevance are real, not rhetorical.

Reviewers also check human subject protections and ethical frameworks, especially for clinical research outside trials.

Funding decisions are merit-based after review stage and then policy/funding fit-based, with NIH policy and relevance factors overlaid by institute priorities and budget availability.

What matters most for success is program coherence. A technically excellent single project can lose to a less “exciting” but structurally coherent center with clear shared outputs.

Common mistakes to avoid

1. Treating this as a normal single proposal. A P01 CCRC is judged as an organization, not a standalone PI narrative. Inconsistent structure between components will be penalized.

2. Forgetting the “no clinical trials” rule. Clinical research can be included, but only non-trial designs. Any trial-proposing activity disqualifies compliance or creates major review risk.

3. Submitting late due to registration dependencies. SAM, eRA Commons, and institutional signatures are usually the first delays. Build those into your schedule.

4. Overstating foreign participation through disallowed subawards. The NOFO allows some foreign components in narrow contexts but not foreign subawards under this mechanism.

5. Ignoring the DRP as a talent strategy. Underused DRP capacity weakens the practical argument that this is a multi-project ecosystem with growth and succession.

6. Insufficiently connecting projects. If every project can be described independently without shared dependency, it may fail to justify the P01 center model.

7. Weak facilities narrative around endemic-region advantages. The NOFO’s scientific rationale expects unique use of endemic-region resources and patient material.

Practical preparation timeline (recommended)

For teams planning to target this in 2026:

6–8 weeks before the deadline

• Confirm institutional registrations are active and stable.
• Appoint PD/PI(s), project leaders, and drafting team.
• Confirm which pieces are core requirements versus optional.
• Build the center logic diagram that maps each project to shared goals.

4–6 weeks before

• Lock the overall concept and project boundaries.
• Draft DRP policy and early investigator support plan.
• Collect letters and administrative documents from collaborators.
• Ensure each required component has explicit page-limit-compliant drafts.

2–3 weeks before

• Run an internal NIH-form compliance pass.
• Confirm required eRA/ASSIST fields, budget assumptions, and internal approvals.
• Re-check non-responsiveness rules (especially no non-coccidioides disease focus).
• Build reviewer-facing summary tables for each component.

1 week before

• Final integration pass for the center-level narrative.
• Confirm no disqualifying foreign subaward path.
• Submit early to allow system validation and corrections before local deadline.

The NOFO itself says applicants are encouraged to submit early because correction opportunities close at the final deadline.

Evidence quality and applicant strategy

The strongest CCRC proposals usually present two kinds of evidence:

• Depth evidence: scientific maturity, preliminary findings, sample access, method quality.
• Architecture evidence: documented coordination, shared governance, and measurable integration.

For this opportunity, evidence quality is judged not only at project level but at system level. Make your evidence architecture explicit:

• include a one-page “integration map” showing patient sample flow, translational outputs, and feedback loops;
• show how DRP outputs feed broader center projects and reduce delays;
• provide project dependencies and expected knowledge transfer each year.

If you can show this clearly, the proposal reads like a research engine. If you cannot, it reads like four disconnected proposals under one cover.

How this compares with other NIH calls

If your timeline is too compressed for a center-style submission, similar objectives might be pursued through:

• smaller mechanism project grants at the project level,
• disease-focused R01 or U-series mechanisms, or
• collaborative mechanisms outside NIH.

This opportunity is better when your ask is clearly collaborative and regional, and you have capacity for coordination in a multi-year center format. It is less suitable if your project is a single-lab discovery effort without cross-institutional breadth.

In practical terms: use this NOFO when the answer to “why not run this as one award?” is “because the work needs shared cores, shared cohorts, and shared governance.”

FAQ

Is this a P01 or a P30?

It is listed as P01 Clinical Trial Not Allowed in the official announcement content.

Can foreign organizations apply as lead?

No. Foreign organizations are not eligible as direct applicants, and foreign subawards are generally not accepted under this NOFO.

Is this currently open in 2026?

The opportunity is listed with a posted date in May 2026 and a July 2026 due date. That makes it a valid 2026 cycle target, with FY2027 funding intent.

What is the maximum budget?

The NOFO indicates applications are not expected to exceed $1.2M direct costs/year and says NIAID intends to commit $4.8M in FY 2027 across 3–4 awards.

Is this only for clinical trial proposals?

No. It explicitly does not allow clinical trials.

Who can apply?

Eligible U.S. institutions are broad (universities, nonprofits, for-profits, and government units), but only one application per institution.

Official links and next actions

Use the official NOFO page for definitive instructions and any updates before drafting:

• Official announcement (full text): RFA-AI-27-012-Full-Announcement.html (simpler.grants.gov)
• NIAID Valley fever vaccine strategic context (to align priorities): NIAID Valley fever vaccine strategy page
• NIH application guidance: NIH How to Apply and SF424 (R&R) materials referenced in the NOFO

Before submitting, complete this short internal checklist:

• Confirm domestic eligibility and one-application-per-institution status.
• Confirm no prohibited foreign subcontract pathway.
• Confirm project list includes at least one clinical-research project with Valley fever patient samples.
• Confirm each component is complete and internally consistent with budget and page limits.
• Confirm registration status and PI credentials are complete in SAM/eRA Commons/ORCID.
• Submit before deadline to allow correction of portal-level errors.

This opportunity is not easy to execute, but it is one of the stronger center-style routes for teams that already have meaningful coccidioidomycosis capacity and need a funding structure that rewards organized cross-discipline progress in 2026/2027.