Opportunity Information: Apply for PAR 23 159
Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (PAR-23-159) is a National Institutes of Health (NIH) funding opportunity that supports short, focused clinical research projects aimed at getting rare disease programs ready for future clinical trials. It uses the R21 grant mechanism and explicitly does not allow clinical trials under this announcement, meaning the supported work should be preparatory rather than testing an intervention for efficacy in humans. The main purpose is to remove common bottlenecks that slow rare disease translation by strengthening the evidence, tools, and study infrastructure needed to design high-quality trials later on.
The projects NIH is looking for are those that make it easier to move promising therapeutics or diagnostics toward the clinic by improving the foundations of trial design. A major emphasis is on developing and testing robust biomarkers and clinical outcome assessment measures, because rare diseases often lack validated endpoints, sensitive measures of change, or reliable markers that track disease activity. Another key focus is building a clearer picture of the disease itself, such as carefully defining the clinical presentation, natural history, and progression patterns. This kind of work can directly inform practical trial elements like inclusion and exclusion criteria, stratification approaches, visit schedules, sample size assumptions, endpoint selection, and the time window in which change can realistically be detected.
The announcement falls under the broad federal activity category of Health, Income Security and Social Services, and it is associated with CFDA numbers 93.350 and 93.865. As an NIH discretionary grant program, it is intended to fund targeted, high-value clinical readiness studies rather than large multi-year trial programs. The listed award ceiling is $275,000, indicating a relatively capped budget consistent with the R21 mechanism and the expectation of well-defined, milestone-oriented preparatory aims.
Eligibility is intentionally broad across sectors to encourage participation from the full rare disease ecosystem. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, and U.S. territories or possessions. This breadth is designed to make it feasible for academic centers, patient-focused groups, clinical networks, and industry partners to contribute to readiness work where they have unique strengths.
There are important restrictions related to foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S.-based applicant can include certain international collaborations or activities when they are well-justified and compliant with NIH policy.
Key administrative details include the funding opportunity title and number (Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes; PAR-23-159), the agency (National Institutes of Health), and an original closing date of 2024-10-17. Overall, the opportunity is best suited for teams that can demonstrate a clear path from the proposed readiness activities to a more feasible, better powered, and higher probability-of-success clinical trial in the future, particularly in rare conditions where validated biomarkers, outcomes, or natural history data are currently limiting progress.Apply for PAR 23 159
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (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): 93.350, 93.865.
- This funding opportunity was created on 2023-04-13.
- Applicants must submit their applications by 2024-10-17. (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 $275,000.00 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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Frequently Asked Questions (FAQs)
What is the Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes opportunity (PAR-23-159)?
PAR-23-159 is a National Institutes of Health (NIH) funding opportunity that supports short, focused clinical research projects intended to prepare rare disease programs for future clinical trials. The goal is to remove common bottlenecks that slow translation by building the evidence, tools, and study infrastructure needed to design higher-quality trials later on.
What is the main purpose of this NIH funding opportunity?
The main purpose is clinical trial readiness, not running a full clinical trial. NIH is looking for milestone-oriented, high-value preparatory studies that make future trials more feasible and more likely to succeed by improving trial foundations such as endpoints, biomarkers, outcome assessments, and knowledge of disease progression.
What grant mechanism does this program use?
This opportunity uses the NIH R21 grant mechanism, which aligns with the expectation of well-defined, targeted aims focused on addressing specific readiness gaps.
Are clinical trials allowed under PAR-23-159?
No. This announcement explicitly does not allow clinical trials. The supported work must be preparatory in nature and should not involve testing an intervention for efficacy in humans.
What kinds of projects is NIH looking to fund under this announcement?
NIH is seeking projects that move promising therapeutics or diagnostics toward the clinic by strengthening the building blocks of trial design. Examples described in the opportunity include efforts to develop and test robust biomarkers and clinical outcome assessment measures, and work that clarifies clinical presentation, natural history, and progression patterns in rare diseases.
Why are biomarkers and clinical outcome assessments emphasized for rare diseases?
Rare diseases often lack validated endpoints, sensitive measures of change, or reliable markers that track disease activity. This opportunity emphasizes developing and testing biomarkers and outcome assessment measures to help future trials select meaningful endpoints and detect change within realistic time windows.
How can natural history or disease characterization work support future trials?
By carefully defining the clinical presentation, natural history, and progression patterns, readiness studies can directly inform practical trial elements such as inclusion and exclusion criteria, stratification approaches, visit schedules, sample size assumptions, endpoint selection, and identifying when change can realistically be detected.
What is meant by addressing "bottlenecks" in rare disease translation?
In the context of this opportunity, bottlenecks are common obstacles that slow movement from early research toward clinical trials, such as missing or weak evidence for endpoints, lack of validated biomarkers, limited understanding of disease progression, or insufficient study infrastructure to design a high-quality trial.
What is the award ceiling for this opportunity?
The listed award ceiling is $275,000, reflecting a relatively capped budget consistent with the R21 mechanism and an expectation of focused, readiness-oriented aims.
What federal activity category is associated with this opportunity?
The announcement falls under the broad federal activity category of Health, Income Security and Social Services.
Which CFDA numbers are associated with PAR-23-159?
This opportunity is associated with CFDA numbers 93.350 and 93.865.
Who is eligible to apply?
Eligibility is broad and includes state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.
Are specific institution types explicitly called out as eligible?
Yes. The FOA also calls out additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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, and U.S. territories or possessions.
Why is eligibility so broad for this program?
The broad eligibility is intended to encourage participation from across the rare disease ecosystem, making it feasible for academic centers, patient-focused groups, clinical networks, and industry partners to contribute where they have unique strengths in readiness work.
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization under this opportunity.
Can non-domestic components of U.S. organizations apply?
No. Non-domestic components of U.S. organizations are not eligible to apply under this announcement.
Are any international collaborations allowed at all?
Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant can include certain international collaborations or activities when well-justified and compliant with NIH policy.
What does "clinical trial readiness" look like in practice for this FOA?
Based on the description provided, clinical trial readiness includes strengthening the foundations needed to design high-quality trials later, such as validating or improving biomarkers and outcome assessments, clarifying natural history and progression, and producing information that supports key design choices (eligibility criteria, stratification, visit schedules, sample size assumptions, and endpoint selection).
Is this intended to fund large, multi-year clinical trial programs?
No. As an NIH discretionary grant program, it is intended to fund targeted, high-value clinical readiness studies rather than large multi-year trial programs.
What is the deadline mentioned for this opportunity?
The information provided lists an original closing date of 2024-10-17.
Who is the funding agency for PAR-23-159?
The funding agency is the National Institutes of Health (NIH).
What types of teams are a good fit for this opportunity?
The opportunity is best suited for teams that can show a clear path from the proposed readiness activities to a future clinical trial that is more feasible, better powered, and has a higher probability of success, particularly in rare conditions where progress is limited by lack of validated biomarkers, outcome measures, or natural history data.
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