Opportunity Information: Apply for PA 19 081
The National Institutes of Health (NIH) funding opportunity "Advancing Development of Rapid Fungal Diagnostics (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number PA 19 081) supports early-stage, exploratory research aimed at creating better fungal diagnostic tests that work quickly and reliably in real-world clinical settings. The central focus is on developing diagnostics that are rapid, highly sensitive and specific, simple to use, and cost-effective, with an emphasis on primary health-care environments such as hospitals and point-of-care locations where timely answers can directly improve patient management. Because this is an R21 mechanism, it is geared toward proof-of-concept, prototyping, feasibility testing, and other high-impact exploratory work rather than large-scale validation studies, and it explicitly does not allow clinical trials under this announcement.
The opportunity falls under the Health funding activity category and uses the grant funding instrument type. The program is structured to encourage innovation in fungal testing approaches that can shorten the time from patient presentation to actionable results, which is a common bottleneck in fungal disease care. In practical terms, NIH is looking for diagnostic concepts or devices that can be deployed where care is delivered, including near-patient testing, workflows compatible with routine hospital operations, and platforms that do not require extensive specialized training or expensive laboratory infrastructure. The ideal outputs are assays or diagnostic systems that reduce complexity and cost while maintaining strong analytic performance, helping clinicians identify fungal infections faster and more accurately.
Eligibility is broad and includes many types of U.S.-based organizations as well as certain non-U.S. entities. Eligible applicants include state, county, city or township, and special district governments; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (foreign) organizations, indicating an intent to draw participation from a wide range of communities and institutional types.
From the funding details provided, the award ceiling is listed as $200,000. The original closing date shown in the source data is 2022-01-07, and the opportunity record notes a creation date of 2018-11-26. The CFDA number associated with the program is 93.855. Overall, the announcement is designed to push forward practical diagnostic innovations for fungal diseases, especially those that can be used at the bedside or in routine clinical care settings, while keeping the work in the non-clinical-trial research space appropriate for the R21 exploratory grant format.Apply for PA 19 081
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Development of Rapid Fungal Diagnostics (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2018-11-26.
- Applicants must submit their applications by 2022-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIH PA-19-081 - Advancing Development of Rapid Fungal Diagnostics (R21 Clinical Trial Not Allowed)
1) What is the goal of this NIH funding opportunity?
The goal is to support early-stage, exploratory research to create better fungal diagnostic tests that work quickly and reliably in real-world clinical settings. The emphasis is on diagnostics that are rapid, highly sensitive and specific, simple to use, and cost-effective, especially in primary health-care environments like hospitals and point-of-care locations where fast results can improve patient management.
2) What is the funding opportunity number and title?
Funding Opportunity Number: PA 19 081
Title: Advancing Development of Rapid Fungal Diagnostics (R21 Clinical Trial Not Allowed)
3) What type of research is NIH looking to fund under this announcement?
This R21 announcement is geared toward proof-of-concept work, prototyping, feasibility testing, and other high-impact exploratory activities aimed at advancing rapid fungal diagnostics. It is positioned for early-stage development rather than large-scale validation efforts.
4) Are clinical trials allowed under this opportunity?
No. Clinical trials are explicitly not allowed under this announcement.
5) What kinds of diagnostic characteristics are emphasized?
The announcement emphasizes diagnostics that are:
- Rapid (shortening time from patient presentation to actionable results)
- Highly sensitive and specific
- Simple to use
- Cost-effective
- Practical for real-world clinical workflows, including near-patient and routine hospital operations
- Compatible with settings that lack extensive specialized training or expensive laboratory infrastructure
6) What settings are prioritized for use of the diagnostics?
Priority is placed on primary health-care environments, including hospitals and point-of-care (near-patient) locations. The intent is to enable testing where care is delivered, so results can influence patient management without long delays.
7) What problem is this program trying to address?
A central issue highlighted is the bottleneck in fungal disease care caused by delays between patient presentation and actionable diagnostic results. The program aims to accelerate that timeline by supporting innovative fungal testing approaches that provide faster answers while maintaining strong analytic performance.
8) What stage of development is most appropriate for an R21 under this announcement?
The R21 mechanism described here is most appropriate for early-stage development work such as feasibility studies, prototyping, and proof-of-concept demonstrations. It is not positioned as a mechanism for large-scale validation studies.
9) What is the funding category and instrument type?
Funding activity category: Health
Funding instrument type: Grant
10) What is the award ceiling listed for this opportunity?
The award ceiling listed in the provided information is $200,000.
11) Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations as well as certain non-U.S. entities. Eligible applicants include:
- State governments
- County governments
- City or township governments
- Special district governments
- Federally recognized Native American tribal governments
- Native American tribal organizations (other than federally recognized tribal governments)
- Public housing authorities / Indian housing authorities
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofits with 501(c)(3) status (other than institutions of higher education, when specified)
- Nonprofits without 501(c)(3) status (other than institutions of higher education, when specified)
- For-profit organizations (other than small businesses)
- Small businesses
12) Does the announcement encourage participation from specific institution types or communities?
Yes. The announcement highlights additional eligible applicant categories, indicating an intent to draw participation broadly, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISISs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Faith-based or community-based organizations
- Eligible federal agencies
- Regional organizations
- U.S. territories or possessions
- Non-domestic (foreign) organizations
13) Are foreign (non-U.S.) organizations eligible?
Yes. The provided information indicates that non-domestic (foreign) organizations are included among the eligible applicant categories.
14) What kinds of deliverables or outputs does NIH appear to want from funded projects?
The ideal outputs described are assays or diagnostic systems that reduce complexity and cost while maintaining strong analytic performance, and that can be deployed in real-world clinical care settings (including bedside or point-of-care contexts) to help clinicians identify fungal infections faster and more accurately.
15) What is the CFDA number associated with this program?
The CFDA number listed is 93.855.
16) What dates are provided for this opportunity?
The opportunity record notes:
- Creation date: 2018-11-26
- Original closing date shown: 2022-01-07
17) Is this opportunity focused on real-world clinical deployment even though clinical trials are not allowed?
Yes. The focus is on diagnostics that work in real-world clinical settings (such as hospitals and point-of-care locations) and fit routine workflows. At the same time, the announcement keeps the work in the non-clinical-trial research space appropriate for an R21 exploratory grant.
18) What does "rapid" mean in the context of this opportunity?
Based on the description, "rapid" refers to shortening the time between patient presentation and actionable diagnostic results, so clinical decisions and patient management can be improved with timely information.
19) What kinds of operational constraints does NIH want applicants to consider?
The opportunity emphasizes solutions that fit primary care and hospital settings, including workflows compatible with routine operations, platforms that do not require extensive specialized training, and approaches that avoid reliance on expensive laboratory infrastructure, while still achieving high sensitivity and specificity.
20) Is the program aimed at incremental improvements or innovation?
The program is structured to encourage innovation in fungal testing approaches, particularly concepts that can meaningfully reduce time-to-result and improve practical deployment in clinical care environments.
Browse more opportunities from the same category: Health
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Previous opportunity: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
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| Heal Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required) Apply for RFA AT 19 005 Funding Number: RFA AT 19 005 Agency: National Institutes of Health Category: Health Funding Amount: $750,000 |
| HEAL Initiative: Stimulating Peripheral Activity to Relieve Conditions (SPARC): Anatomical and Functional Mapping of Pain-Related Visceral Organ Neural Circuitry (U01 Clinical Trial Optional) Apply for RFA RM 19 001 Funding Number: RFA RM 19 001 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Comprehensive Alcohol-HIV/AIDS Research Center (P60 Clinical Trial Optional) Apply for RFA AA 19 003 Funding Number: RFA AA 19 003 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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