Opportunity Information: Apply for PAR 18 550
The grant opportunity titled "Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional)" (Funding Opportunity Number PAR-18-550) is a discretionary National Institutes of Health (NIH) program that uses the cooperative agreement mechanism (U01). Its core aim is to fund projects that carry out rigorous analytical validation of candidate biomarkers, biomarker-based measures, or biomarker-derived endpoints relevant to neurological diseases. The emphasis is on validating how well a biomarker test or measurement performs from an analytical standpoint, meaning the work should demonstrate that the assay or measurement method is reliable, accurate, precise, and otherwise fit-for-purpose for its specific intended use. The opportunity explicitly frames this work as needing to be consistent with U.S. Food and Drug Administration (FDA) guidelines and expectations, reflecting a focus on standards that support downstream regulatory-grade decision making.
In practical terms, the FOA is centered on analytical validation rather than discovery. That means applicants are expected to start with a "candidate" biomarker that already has a scientific rationale and preliminary evidence supporting its relevance, and then build the kind of data package that shows the measurement itself behaves predictably and robustly. Analytical validation typically involves characterizing performance attributes such as accuracy/trueness, precision (repeatability and reproducibility), sensitivity, specificity, limits of detection and quantitation where applicable, linearity and dynamic range, stability, robustness to pre-analytical variables (like collection, processing, storage, and shipping conditions), interference, lot-to-lot consistency, operator/instrument variability, and performance across sites if the assay is meant to be used broadly. The overall goal is to show that the biomarker measurement can be trusted for its intended context, whether that is patient stratification, pharmacodynamic monitoring, disease progression tracking, or another defined use case. The "Clinical Trial Optional" label indicates that a clinical trial is not required but may be included if it is appropriate for supporting the analytical validation plan.
The funding instrument is a cooperative agreement, which typically means NIH expects substantial programmatic involvement during the project compared with a standard research grant. While the specific details of that involvement are not listed in the provided text, cooperative agreements commonly include coordinated milestones, active communication with NIH program staff, and potentially harmonization with broader NIH efforts in biomarker development. The activity category is health, and the CFDA number is 93.853, which corresponds to NIH-supported health research activities in this area.
Eligibility is broad and includes many standard applicant types: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations that are not federally recognized; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories, underscoring inclusivity across institution types and geographies. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, tribal governments that are not federally recognized, and non-U.S. entities (foreign organizations). This breadth suggests the program is open to a wide range of groups capable of conducting high-quality analytical validation work, including entities that can contribute specialized laboratory methods, clinical sample resources, or multi-site coordination.
The opportunity was created on 2017-12-22, and the original closing date listed is 2020-09-07. The source text does not provide an award ceiling or the expected number of awards, so applicants would typically need to consult the full FOA documentation for budget caps, project period limits, and any guidance on anticipated award sizes and counts. Overall, the opportunity is designed for teams that are ready to move beyond biomarker identification and into the demanding, standards-driven phase of proving that a biomarker assay or endpoint can perform consistently and credibly for neurological disease research and, potentially, future clinical or regulatory applications.Apply for PAR 18 550
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2017-12-22.
- Applicants must submit their applications by 2020-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 title and funding opportunity number for this grant?
The opportunity is titled "Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional)" and the Funding Opportunity Number is PAR-18-550.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) discretionary grant opportunity.
What is the main purpose of this funding opportunity?
The core aim is to support rigorous analytical validation of candidate biomarkers, biomarker-based measures, or biomarker-derived endpoints relevant to neurological diseases.
What does "analytical validation" mean in the context of this FOA?
Analytical validation focuses on demonstrating that the biomarker assay or measurement method performs reliably and predictably for its intended use. This includes showing the method is accurate, precise, and fit-for-purpose, and that it can generate trustworthy measurements under defined conditions.
Is this FOA focused on biomarker discovery or on validating existing candidates?
This FOA is centered on analytical validation rather than discovery. Applicants are expected to begin with a candidate biomarker that already has scientific rationale and preliminary evidence supporting its relevance, and then build an analytical performance data package for the measurement.
What kinds of biomarker-related outputs are supported?
The FOA supports analytical validation of candidate biomarkers, biomarker-based measures, and biomarker-derived endpoints relevant to neurological diseases.
What neurological disease areas are relevant to this opportunity?
The opportunity is broadly framed around neurological diseases. The provided information does not restrict the scope to specific neurological conditions.
What performance characteristics are typically evaluated in analytical validation under this FOA?
Analytical validation commonly includes assessing characteristics such as accuracy/trueness, precision (repeatability and reproducibility), sensitivity, specificity, limits of detection and quantitation (where applicable), linearity and dynamic range, stability, robustness to pre-analytical variables (collection, processing, storage, shipping), interference, lot-to-lot consistency, operator/instrument variability, and cross-site performance when intended for broader use.
Why does the FOA mention FDA guidelines and expectations?
The work is expected to be consistent with U.S. Food and Drug Administration (FDA) guidelines and expectations, reflecting an emphasis on standards that can support downstream regulatory-grade decision making.
What does "fit-for-purpose" mean here?
"Fit-for-purpose" means the assay or measurement is validated to the level needed for its specific intended context of use (for example, patient stratification, pharmacodynamic monitoring, disease progression tracking, or another defined use case), rather than being validated only in a general or exploratory way.
What does "Clinical Trial Optional" mean for applicants?
A clinical trial is not required, but one may be included if it is appropriate to support the analytical validation plan.
What is the funding mechanism for this opportunity?
The award uses the cooperative agreement mechanism (U01).
What does it mean that this is a cooperative agreement (U01) rather than a standard grant?
A cooperative agreement typically involves substantial NIH programmatic involvement during the project compared with a standard research grant. While the specific involvement details are not provided here, cooperative agreements commonly include coordinated milestones, active communication with NIH program staff, and potential harmonization with broader NIH biomarker development efforts.
What is the CFDA number associated with this program?
The CFDA number listed is 93.853.
What is the activity category for this funding opportunity?
The activity category is health.
Who is eligible to apply?
Eligibility is broad and includes: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations that are not federally recognized; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses.
Are minority-serving institutions and community-based organizations eligible?
Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.
Are U.S. territories or possessions eligible?
Yes. The FOA lists U.S. territories or possessions as eligible applicant categories.
Can federal agencies apply?
Yes. Eligible federal agencies are included among the eligible applicant categories listed.
Are non-U.S. entities (foreign organizations) eligible to apply?
Yes. The FOA indicates that non-U.S. entities (foreign organizations) are eligible.
Does the provided information include an award ceiling or expected number of awards?
No. The provided text does not include an award ceiling or the expected number of awards.
Does the provided information include budget caps or project period limits?
No. The provided information notes that applicants would typically need to consult the full FOA documentation for budget caps, project period limits, and related guidance.
When was this opportunity created?
The opportunity was created on 2017-12-22.
What is the closing date listed in the provided information?
The original closing date listed is 2020-09-07.
What kinds of projects are a good fit for this FOA?
Projects that are ready to move beyond identifying biomarkers and into standards-driven analytical validation are a good fit. The FOA is designed for teams aiming to demonstrate that a biomarker assay or endpoint performs consistently and credibly for a defined neurological disease-related context of use, potentially supporting future clinical or regulatory applications.
What are examples of intended contexts of use mentioned for validated biomarkers?
The provided information mentions contexts such as patient stratification, pharmacodynamic monitoring, and disease progression tracking, as well as other defined use cases.
Does this FOA emphasize multi-site or cross-site assay performance?
It can. The provided description notes that analytical validation may include performance across sites if the assay is intended to be used broadly.
Does this FOA address pre-analytical factors like sample collection and storage?
Yes. The description highlights robustness to pre-analytical variables such as collection, processing, storage, and shipping conditions as part of typical analytical validation considerations.
Does this FOA consider variability due to operators, instruments, or lots?
Yes. The analytical validation description includes operator/instrument variability and lot-to-lot consistency among the performance attributes that may be characterized.
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