Novel approaches to understand, prevent, treat, and diagnose coccidioidomycosis (Valley Fever) and other select endemic fungal infections (R21 Clinical Trial Not Allowed) | PA 19 083

Frequently Asked Questions (FAQs)

What is the NIH funding opportunity PA-19-083?

PA-19-083 is an NIH funding opportunity announcement for an R21 exploratory/developmental research grant. It is focused on accelerating progress in understanding and combating endemic fungal diseases, with the strongest emphasis on coccidioidomycosis (Valley Fever), and additional included targets such as histoplasmosis and blastomycosis.

What grant mechanism is being used, and what does it imply?

The opportunity uses the NIH R21 mechanism, which is designed to support early-stage, novel, and potentially high-impact research. R21 projects are typically proof-of-concept or hypothesis-generating studies rather than large, multi-year programs, and they are meant to help de-risk innovative ideas that could later be expanded through larger grants.

What is the main scientific focus of this FOA?

The main focus is speeding up progress toward better ways to detect endemic fungal infections earlier, prevent them more effectively, and treat them more successfully. The FOA supports a broad range of foundational and applied research intended to move the field toward improved clinical care and public health control.

Which fungal diseases are specifically highlighted?

The FOA highlights coccidioidomycosis (Valley Fever) as the primary emphasis. It also includes other endemic mycoses such as histoplasmosis and blastomycosis as additional targets.

Are clinical trials allowed under this announcement?

No. The FOA is labeled "Clinical Trial Not Allowed," meaning supported projects should not be interventional clinical trials that assign human participants to treatments. The intended scope is preclinical, translational, mechanistic, or other non-trial research.

What kinds of research areas are considered in scope?

The scientific scope is intentionally broad and includes multiple areas where gaps remain in endemic mycology. The FOA includes work on fungal pathogenesis, host response, transmission and exposure, natural history and environmental determinants, and applied research to enable future vaccines, diagnostics, and therapeutics.

What does "fungal pathogenesis" research mean in this context?

In this FOA, fungal pathogenesis refers to studies on how endemic fungi cause disease and which virulence traits, life-cycle features, or microbial factors drive infection, severity, or dissemination.

What types of "host response" studies fit this opportunity?

Host response research can include immune mechanisms, susceptibility factors, and immune-pathology that help explain why some people clear infection while others develop severe or disseminated disease.

Does the FOA support research on transmission, exposure, or risk?

Yes. The FOA welcomes studies of disease transmission and exposure, including how people become infected and what ecological or epidemiologic dynamics shape risk.

Are environmental and geographic studies relevant here?

Yes. The FOA includes natural history and environmental determinants, which can involve geography, climate, soil or dust exposure, land use, and other conditions that influence fungal persistence and human contact.

Does this opportunity encourage vaccine, diagnostic, or therapeutic research?

Yes. The FOA explicitly encourages forward-looking applied research on vaccines, diagnostics, and therapeutics, including new tools, targets, or approaches that could eventually translate into improved clinical care and public health control.

What is the funding ceiling for this R21 award?

The listed award ceiling is $200,000. This indicates a small, targeted budget aimed at supporting innovative concepts and generating proof-of-concept data.

What is the funding activity category and program listing noted?

The funding activity category is health. The FOA is associated with an NIH program area listed under CFDA 93.855.

Which agency sponsors this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What type of grant program is this considered?

It is categorized as a discretionary grant program.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations as well as certain non-U.S. entities. Eligible applicants include various government entities, educational institutions, nonprofits, for-profits (other than small businesses), and small businesses, along with several additional categories specifically called out in the announcement.

Are state, local, or tribal governments eligible?

Yes. Eligible applicants include state governments, county and local governments, special districts, and Native American tribal governments (federally recognized). The FOA also includes tribal organizations that are not federally recognized.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education. The FOA also calls out institution types such as HBCUs, TCCUs, and other serving institutions.

Are nonprofits eligible to apply?

Yes. Nonprofits with or without 501(c)(3) status are eligible (when not applying as higher education institutions).

Can for-profit organizations apply?

Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.

Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly includes faith-based or community-based organizations among the additional eligible applicant categories.

Can federal agencies apply?

Yes. Eligible federal agencies are included among the additional eligible applicant categories.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA includes U.S. territories or possessions as eligible applicant categories.

Are foreign (non-U.S.) organizations eligible?

Yes. The FOA includes foreign organizations (non-domestic entities) among eligible applicants, indicating certain non-U.S. entities can apply.

What is the intended impact of funding under this FOA?

The FOA is aimed at catalyzing new approaches that clarify how these fungi interact with hosts and environments, and then converting those insights into tangible tools such as improved diagnostic assays, vaccine concepts, or therapeutic strategies. The overarching goal is to reduce missed or delayed diagnoses, improve prevention for high-risk communities, and expand treatment options for serious or complicated infections caused by endemic fungi.

What are the key dates mentioned for this opportunity?

The source record lists a creation date of 2018-11-26 and an original closing date of 2022-01-07. Applicants would need to verify the current status, any reissues, or updated due dates through NIH systems before applying.

Is the scope limited to a single disease or region?

No. While the main emphasis is on Valley Fever (coccidioidomycosis), the FOA includes other endemic fungal diseases such as histoplasmosis and blastomycosis, and it supports broad research areas spanning biology, host factors, transmission, and environmental determinants.

Does the FOA emphasize early-stage or established research?

The FOA emphasizes early-stage, novel, and potentially high-impact ideas appropriate for an R21 exploratory/developmental grant, with the intent to generate proof-of-concept data and validate promising hypotheses.