Opportunity Information: Apply for PAR 16 166
Apply for PAR 16 166
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Integrating Biospecimen Science into Clinical Assay Development (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394,.
- This funding opportunity was created on Apr 05, 2016 and posted on Apr 05, 2016.
- Applicants must submit their applications by Jun 22, 2017. (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 $250,000.00 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 (see text field entitled Additional Information on Eligibility for clarification).
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
Integrating Biospecimen Science into Clinical Assay Development (U01) is a National Institutes of Health funding opportunity (through HHS/NIH, tied to NCI priorities) focused on a practical but persistent problem in clinical biomarker testing: results can shift not because the assay is flawed, but because biopsy specimens are collected, handled, processed, or stored differently before the test ever begins. This FOA funds extramural research meant to identify where that preanalytical variability is introduced, measure how much it changes assay readouts, and develop ways to prevent or reduce those effects so that clinical assays perform more reliably when used in real-world clinical trials and, ultimately, patient care.
The core scientific goal is to strengthen clinical assay development by integrating biospecimen science directly into the assay pipeline. In many biomarker programs, assay optimization gets most of the attention while the earlier steps (how tissue is taken from a patient, time to stabilization, fixation conditions, freezing approach, transport temperature, storage duration, and similar variables) are treated as background details. This announcement flips that assumption and supports studies that connect those upstream handling factors to downstream analytical performance for both current and emerging biomarkers. In other words, it is designed to produce evidence that clarifies which biopsy handling variables matter, how they affect sensitivity, specificity, accuracy, precision, reproducibility, limits of detection, and overall assay robustness, and what standardized practices can be adopted to keep results consistent across sites.
A major programmatic point is alignment with NCI-sponsored clinical trials and existing efforts to optimize clinical biomarker assays used in those trials. The intent is not just to publish observations about biospecimen variability, but to generate actionable findings that can be translated into standardized, evidence-based biopsy handling practices. By doing so, the program aims to accelerate assay development timelines, cut down on costly late-stage assay failures, and improve confidence that biomarker-driven decisions in trials are based on stable and comparable measurements rather than artifacts of inconsistent specimen handling.
Mechanistically, the award uses the U01 cooperative agreement format, which typically indicates substantial programmatic involvement from the NIH compared with a standard research grant. That structure is commonly used when the funder expects close coordination, shared milestones, harmonization across projects, or integration with broader NCI assay and trial infrastructure. The funding instrument is listed as a Cooperative Agreement under a discretionary opportunity category, with activity areas in education and health and CFDA numbers 93.393 and 93.394.
Eligibility is broad and includes many organization types that could contribute to the needed multidisciplinary work. Eligible applicants include state, county, and 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations other than small businesses; and small businesses, with additional eligibility details referenced in the announcement. This wide net fits the reality that solving preanalytical variability often requires collaboration among clinical sites, pathology and biorepository operations, assay development labs, academic methodologists, and industry-adjacent developers.
Key administrative details from the opportunity record include the Funding Opportunity Number PAR-16-166 and the title Integrating Biospecimen Science into Clinical Assay Development (U01). It was posted and created on April 5, 2016, and the listed closing date was June 22, 2017. The award ceiling is shown as $250,000. The record also lists expected awards, though the number is not provided in the source text shown.
Overall, the program is best understood as an effort to make biomarker assays more trustworthy by treating the biopsy specimen as part of the measurement system, not just the starting material. By generating rigorous data on how preanalytical factors influence biomarker readouts and by pushing for evidence-based standardization of biopsy handling, the FOA targets three practical outcomes: improved reliability of clinical biomarker assays, shorter and less risky development cycles, and fewer failures when assays are tested in demanding, late-stage clinical trial settings.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Integrating Biospecimen Science into Clinical Assay Development (U01).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-16-166.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) funding opportunity under HHS/NIH, tied to National Cancer Institute (NCI) priorities.
What is the main problem this FOA is trying to solve?
The FOA targets preanalytical variability in clinical biomarker testing, where assay results can change because biopsy specimens are collected, handled, processed, transported, or stored differently before the assay begins, even if the assay itself is technically sound.
What is the overall scientific goal of the program?
The core goal is to integrate biospecimen science directly into clinical assay development so that upstream specimen handling factors are studied alongside assay optimization, producing evidence about which factors matter, how much they affect readouts, and how to reduce or prevent those effects.
What types of research activities does the FOA support?
It supports extramural research intended to: (1) identify where preanalytical variability is introduced, (2) measure how much that variability changes assay results, and (3) develop methods and practices to prevent or reduce those effects so assays perform more reliably in real-world clinical trials and, ultimately, patient care.
What are examples of preanalytical variables that may be studied under this program?
Examples mentioned include biopsy collection and handling factors such as time to stabilization, fixation conditions, freezing approach, transport temperature, storage duration, and similar upstream conditions that occur before testing begins.
How does this FOA differ from typical biomarker assay development efforts?
Many biomarker programs focus heavily on assay optimization while treating specimen handling details as background. This FOA explicitly shifts that approach by funding studies that connect specimen handling factors to downstream assay performance, making the specimen part of the measurement system rather than just starting material.
What assay performance characteristics does the FOA emphasize?
The FOA emphasizes understanding how preanalytical factors affect analytical performance measures such as sensitivity, specificity, accuracy, precision, reproducibility, limits of detection, and overall assay robustness.
What is the intended impact on clinical trials and patient care?
The intent is to improve the reliability and comparability of biomarker measurements across sites so biomarker-driven decisions in trials are based on stable measurements rather than artifacts of inconsistent specimen handling, supporting eventual translation into patient care.
How does this FOA relate to NCI-sponsored clinical trials?
A major programmatic point is alignment with NCI-sponsored clinical trials and ongoing efforts to optimize clinical biomarker assays used in those trials. The FOA aims to generate findings that can be translated into standardized, evidence-based biopsy handling practices that fit within that broader clinical trial infrastructure.
Is the goal only to publish findings about biospecimen variability?
No. The FOA stresses producing actionable findings that can be translated into standardized, evidence-based biopsy handling practices, not just observational publications.
What practical outcomes is the program aiming for?
The described practical outcomes include: (1) improved reliability of clinical biomarker assays, (2) shorter and less risky assay development cycles, and (3) fewer late-stage failures when assays are tested in demanding clinical trial settings.
What type of award mechanism is used?
The opportunity uses a U01 cooperative agreement mechanism.
What does it mean that this is a U01 cooperative agreement?
Based on the description provided, the cooperative agreement format typically indicates substantial programmatic involvement from NIH compared with a standard research grant, often involving close coordination, shared milestones, harmonization across projects, or integration with broader NCI assay and trial infrastructure.
What is the opportunity category and activity areas listed?
The record lists the instrument as a Cooperative Agreement under a discretionary opportunity category, with activity areas in education and health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.393 and 93.394.
Who is eligible to apply?
Eligibility is broad and includes the following types of applicants (as listed):
- State governments
- County governments
- 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
- Other Native American tribal organizations
- Public housing authorities / Indian housing authorities
- Nonprofits with 501(c)(3) status (excluding higher education institutions where applicable)
- Nonprofits without 501(c)(3) status (excluding higher education institutions where applicable)
- For-profit organizations other than small businesses
- Small businesses
Why is eligibility described as broad for this FOA?
The description notes that reducing preanalytical variability often requires multidisciplinary collaboration across clinical sites, pathology and biorepository operations, assay development labs, academic methodologists, and industry-adjacent developers. The wide eligibility reflects that reality.
What is the award ceiling listed in the opportunity record?
The award ceiling shown is $250,000.
When was this opportunity posted and created?
The record states it was posted and created on April 5, 2016.
What closing date is listed for this opportunity?
The listed closing date is June 22, 2017.
How many awards are expected?
The record indicates that expected awards are listed, but the number of expected awards is not provided in the information shown.
In plain terms, what is this FOA trying to change about biomarker testing?
It is designed to make biomarker assays more trustworthy by treating the biopsy specimen and its handling as a core part of the measurement system, generating data to standardize practices so assay results remain consistent across sites and conditions.
Browse more opportunities from the same category: Education, Health
Next opportunity: Justice Sector Support Project (JSSP)
Previous opportunity: Establishment of Resource Centers for Dental, Oral and Craniofacial Tissue Regeneration Consortium (U24)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 16 166
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 166) also looked into and applied for these:
| Funding Opportunity |
|---|
| Novel Strategies for Targeting HIV-CNS Reservoirs without Reactivation (R01) Apply for RFA MH 17 101 Funding Number: RFA MH 17 101 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Novel Strategies for Targeting HIV-CNS Reservoirs without Reactivation (R21) Apply for RFA MH 17 100 Funding Number: RFA MH 17 100 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Pilot and Feasibility Studies Evaluating the Role of RNA Modifications (the 'epitranscriptome') in Cancer Biology (R21) Apply for PA 16 177 Funding Number: PA 16 177 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Exploratory Grants in Cancer Epidemiology and Genomics Research (R21) Apply for PA 16 175 Funding Number: PA 16 175 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| NCI Clinical and Translational Exploratory/Developmental Studies (R21) Apply for PAR 16 176 Funding Number: PAR 16 176 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Improved Technologies and Ligands for Non-invasive Brain Imaging (R43/R44) Apply for RFA DA 17 011 Funding Number: RFA DA 17 011 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Improved Technologies and Ligands for Non-invasive Brain Imaging (R41/R42) Apply for RFA DA 17 010 Funding Number: RFA DA 17 010 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Paul Calabresi Career Development Award for Clinical Oncology (K12) Apply for PAR 16 189 Funding Number: PAR 16 189 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Tools for Cell Line Identification (R43/R44) Apply for PA 16 186 Funding Number: PA 16 186 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research (R43/R44) Apply for RFA DA 17 017 Funding Number: RFA DA 17 017 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $150,000 |
| Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research (R41) Apply for RFA DA 17 016 Funding Number: RFA DA 17 016 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $150,000 |
| Improving Smoking Cessation in Socioeconomically Disadvantaged Populations via Scalable Interventions (R01) Apply for PAR 16 202 Funding Number: PAR 16 202 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Improving Smoking Cessation in Socioeconomically Disadvantaged Populations via Scalable Interventions (R21) Apply for PAR 16 201 Funding Number: PAR 16 201 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Growing Great Ideas: Research Education Course in Product Development and Entrepreneurship for Life Science Researchers (R25) Apply for RFA DA 17 007 Funding Number: RFA DA 17 007 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $250,000 |
| NLM Career Development Award in Biomedical Informatics and Data Science (K01) Apply for PAR 16 204 Funding Number: PAR 16 204 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Leveraging Cognitive Neuroscience to Improve Assessment of Cancer Treatment-Related Cognitive Impairment (R21) Apply for PAR 16 213 Funding Number: PAR 16 213 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| Leveraging Cognitive Neuroscience Research to Improve Assessment of Cancer Treatment Related Cognitive Impairment (R01) Apply for PAR 16 212 Funding Number: PAR 16 212 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Extracellular Vesicle Tools, Technologies, and Products for Neuroscience Research (R43/R44) Apply for RFA DA 17 009 Funding Number: RFA DA 17 009 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $150,000 |
| Extracellular Vesicle Tools, Technologies, and Products for Neuroscience Research (R41/R42) Apply for RFA DA 17 008 Funding Number: RFA DA 17 008 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $150,000 |
| Research Answers to NCIs Pediatric Provocative Questions (R21) Apply for PAR 16 217 Funding Number: PAR 16 217 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 16 166", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.