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 was a 2026 NIH funding opportunity for teams that could build coordinated biomedical programs around Valley fever, formally known as coccidioidomycosis. Unlike single-project grants, it funded a center-like structure under NIH activity code P01 (research program projects) and explicitly excluded clinical-trial proposals. The official listing now marks the competition closed, so this page is a historical reference for the published cycle rather than an invitation to submit.

If you are assessing whether the published cycle matched your organization, use this filter:

• The applicant had to be an eligible domestic organization, with only one application permitted per institution.
• The team needed a multi-project structure with an Administrative Core, at least two Research Projects, and shared resources where justified.
• At least one Research Project needed clinical research using Valley fever patient samples from endemic areas, while clinical trials were not allowed.

The NOFO accepted new applications through 2026-07-09 at 5:00 PM local time of the applicant organization. The official announcement gives an expiration date of 2026-07-10 and lists an earliest start date of March 2027. No later cycle is identified in the source checked for this update. Do not treat the closed date as a current application window; use a newly issued NIAID or Grants.gov notice if a future competition is announced.

Key details

Why this opportunity existed and why it was timed for 2026/2027

The announcement text identifies Valley fever as a serious infection associated with arid regions and explains that continued support is needed to move foundational work, genetic tools, potential immunogens, and host-response research toward a vaccine. NIAID framed CCRC as a mechanism to connect discovery, patient-derived evidence, translational development, and shared support services under one multi-project umbrella.

The published schedule had several important stages:

1. The notice was posted on May 4, 2026, opened for earliest submission on June 9, 2026, and set the new-application deadline for July 9, 2026.
2. Scientific merit review was listed for November 2026, advisory council review for January 2027, and the earliest start date for March 2027.

That schedule made the call useful to teams that already had shared assays, regional patient cohorts, and at least two robust research tracks when the round opened. It was not a small pilot award or a mechanism for forming a collaboration after the deadline. Because the source does not announce a successor round, the published schedule should be retained as historical context and not reused as a future deadline.

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.
• Non-domestic components of U.S. organizations are not eligible to apply as the applicant entity.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed, but applications involving foreign subawards or subcontracts are not eligible 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 the published cycle

A practical interpretation of the official dates is:

• May 4, 2026: the notice was posted.
• June 9, 2026: the earliest submission date.
• July 9, 2026: the new-application deadline, at 5:00 PM local time of the applicant organization.
• July 10, 2026: the expiration date.
• November 2026 / January 2027 / March 2027: scientific merit review, advisory council review, and earliest start, respectively.

These markers were useful for scheduling before the cycle closed:

1. A team still building a full center concept in late June would have had little time to complete the required multi-project package before the July deadline.
2. A team already running coccidioidomycosis research could have used the mechanism to present a stronger multi-core strategy, provided it met the patient-sample and domestic-applicant requirements.
3. After July 9, the page should not direct applicants to submit for this round. A future submission would require a new notice and a new deadline.

Application format and submission mechanics

This was an NIH-specific process with heavy compliance dependency. It is now closed, but the steps below explain the application route documented in the announcement and help readers distinguish the historical mechanism from an active call:

• 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, applicants had 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 the required component structure; its Multi-Project (M) instructions and application guide supplied the applicable 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 states that non-trial clinical research can be included, but no clinical trials may be proposed. At least one Research Project must use Valley fever patient samples from endemic areas. That requirement is central to responsiveness, not an optional enhancement.

Application status and historical application steps

The official listing is marked Closed: July 9, 2026. The source checked for this update does not announce a late-submission window or a next CCRC cycle. Accordingly, there is no current application to submit on this page. Readers evaluating the archived round should use the following sequence:

1. Confirm that they are reviewing the correct funding number, RFA-AI-27-012, and the full announcement rather than a summary copied to a third-party site.
2. Check the domestic-entity, one-application-per-institution, registration, and foreign-collaboration rules against the organization’s grants office records.
3. Build the required Administrative Core, Development and Research Program, and at least two Research Projects around one common theme; add no more than two optional Cores and justify support for at least two Research Projects for each.
4. Include at least one Research Project with clinical research using Valley fever patient samples from endemic areas, while excluding clinical-trial activity.
5. For the closed round, recognize that the submission deadline has passed. For any future round, follow only the date, forms, and instructions in the newly published NIAID or Grants.gov notice.

This distinction matters because the announcement’s scientific and budget details remain useful for historical comparison, but its July 2026 submission instruction is no longer actionable.

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 for the closed cycle

For teams that prepared to target the published cycle, a sensible internal sequence before the July 9, 2026 deadline would have been:

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 encouraged applicants to submit early because correction opportunities close at the final deadline. That advice applied to the closed cycle; it is not evidence that submissions remain open now.

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?

No. The official listing marks the opportunity closed on July 9, 2026. Its published cycle included FY 2027 funding intent, but the source checked for this update does not announce a next round.

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 document as the definitive historical record for this cycle. For a future application, do not rely on this page until NIAID or Grants.gov publishes a new notice:

• 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

For archival review, the relevant checklist is:

• 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.
• Note that the July 9, 2026 deadline has passed; wait for a new official notice before treating any date as actionable.

This opportunity was not easy to execute, but it offered a strong center-style route for teams that already had meaningful coccidioidomycosis capacity and needed a funding structure that rewarded organized cross-discipline progress. The closed status, the real July 9, 2026 deadline, and the absence of an announced next cycle should remain visible so readers do not mistake an archive entry for a live opportunity.