Opportunity Information: Apply for PA 16 075
Apply for PA 16 075
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279,.
- This funding opportunity was created on Jan 08, 2016 and posted on Jan 08, 2016.
- Applicants must submit their applications by Sep 07, 2018. (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 (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:
The grant opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21)" (Funding Opportunity Number PA-16-075) is a discretionary federal grant program offered by the U.S. Department of Health and Human Services through the National Institutes of Health (listed as HHS-NIH11). It was posted and created on January 8, 2016, with an application closing date of September 7, 2018. The opportunity uses the NIH R21 mechanism, which is commonly intended for exploratory and developmental research projects that are earlier-stage, higher-risk, or aimed at proving feasibility and generating the kind of preliminary evidence that can support a later, larger clinical or translational effort.
The core purpose of the FOA is to stimulate the development and clinical testing of minimally invasive or non-invasive bioassays that can strengthen outpatient clinical trials of medications intended to treat Substance Use Disorders (SUDs). In practical terms, the program is focused on measurement tools and biological assays that can be used in real-world outpatient settings, where frequent clinic visits, invasive sampling, or complex laboratory procedures can be difficult to implement and can reduce participant retention and data quality. By encouraging easier, lower-burden assessment methods, the FOA is aiming to improve how researchers monitor drug exposure, treatment adherence, substance use, relapse, and other clinically meaningful indicators during outpatient pharmacotherapy trials for SUDs.
Because the announcement explicitly emphasizes "clinical development" of these assays, the intent is not just basic biomarker discovery, but work that moves an assay toward usability in clinical trial contexts. That generally implies attention to factors like feasibility in outpatient workflows, acceptability to participants, reliability and repeatability, and the ability to produce interpretable results under real trial conditions. The emphasis on minimally invasive approaches suggests examples such as saliva-based testing, breath-based measures, sweat or transdermal monitoring, urine alternatives that reduce collection burden, or other approaches that avoid venipuncture or frequent in-person procedures. The FOA description highlights non-invasive methods broadly, leaving room for a range of technical approaches as long as they are designed to support outpatient clinical trials of SUD therapeutics.
Eligibility for this grant is broad and includes many types of organizations that commonly participate in NIH-funded research. Eligible applicants include state, county, and local 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 and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The listing also notes an "Others" category with additional eligibility details referenced elsewhere in the full announcement, which is typical of NIH postings that allow a wide range of domestic research-performing entities to apply as long as they meet NIH policy requirements.
From an administrative standpoint, the opportunity is categorized under Education and Health funding activity and is associated with CFDA numbers 93.279 (and also referenced as 93.279 in the listing). The posted summary does not provide an award ceiling or an expected number of awards, which usually means applicants need to consult the full FOA text and NIH institute funding policies to understand typical budget limits and award patterns for R21s under the relevant institutes. Even without those figures in the summary, the R21 mechanism itself signals a smaller, time-limited project designed to generate strong proof-of-concept data rather than to fund a full-scale clinical trial.
Overall, this FOA is best understood as a targeted call for practical, patient-friendly biological measurement tools that make outpatient medication trials for substance use disorders more workable and more informative. The emphasis is on reducing invasiveness and logistical burden while improving the ability of researchers to capture objective, clinically relevant data in outpatient settings where most SUD care and many SUD trials are conducted.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R21)" and the Funding Opportunity Number is PA-16-075.
Which federal agency is offering this grant?
This is a discretionary federal grant program offered by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH), listed as HHS-NIH11.
When was the opportunity posted and when does it close?
The opportunity was posted (and created) on January 8, 2016. The application closing date listed is September 7, 2018.
What funding mechanism does this opportunity use?
This opportunity uses the NIH R21 mechanism. R21 awards are commonly intended for exploratory and developmental research projects, often earlier-stage and higher-risk, and aimed at demonstrating feasibility and generating preliminary evidence to support later, larger clinical or translational efforts.
What is the main purpose of this FOA?
The core purpose is to stimulate the development and clinical testing of minimally invasive or non-invasive bioassays that can strengthen outpatient clinical trials of medications intended to treat Substance Use Disorders (SUDs).
What kinds of clinical trials does the FOA aim to support?
It is focused on outpatient clinical trials of therapeutics (medications) for Substance Use Disorders, where real-world constraints can make frequent visits, invasive sampling, or complex lab procedures difficult to implement.
Why is there an emphasis on outpatient settings?
Outpatient trials can be harder to run when assessments require frequent clinic visits or invasive/complex procedures. The FOA emphasizes outpatient usability to help reduce participant burden, support retention, and improve data quality under real trial conditions.
What does "minimally invasive" or "non-invasive" mean in the context of this grant?
The intent is to encourage biological measurement approaches that reduce invasiveness and logistical burden compared with more invasive sampling (for example, venipuncture) or procedures that require frequent in-person visits.
What are examples of bioassays or measurement approaches that fit this FOA?
The summary suggests examples such as saliva-based testing, breath-based measures, sweat or transdermal monitoring, urine alternatives that reduce collection burden, and other approaches that avoid venipuncture or frequent in-person procedures. The FOA leaves room for a range of technical approaches as long as they are designed to support outpatient SUD therapeutic trials.
Is this opportunity meant for basic biomarker discovery?
The announcement emphasizes "clinical development" of assays, indicating the intent is not just basic biomarker discovery, but work that moves an assay toward practical usability in clinical trial contexts.
What does "clinical development" of an assay imply for applicants?
Based on the summary, "clinical development" generally implies attention to real-world trial usability, such as feasibility in outpatient workflows, acceptability to participants, reliability and repeatability, and the ability to generate interpretable results under actual clinical trial conditions.
What kinds of outcomes or indicators are these bioassays intended to help monitor?
The FOA is aimed at tools that can improve measurement during outpatient pharmacotherapy trials for SUDs, including monitoring drug exposure, treatment adherence, substance use, relapse, and other clinically meaningful indicators.
Who is eligible to apply for this grant?
Eligibility is broad and includes: state, county, and local 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 and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.
Are tribal entities included in the eligible applicant types?
Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible applicants.
Can nonprofits apply if they do not have 501(c)(3) status?
Yes. The eligibility list includes nonprofit organizations with and without 501(c)(3) status.
Can for-profit organizations apply?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it also lists small businesses separately as eligible.
Does the listing indicate any additional eligibility categories?
Yes. The listing includes an "Others" category, with additional eligibility details referenced elsewhere in the full announcement, which is typical of NIH postings.
What funding activity category is associated with this opportunity?
The opportunity is categorized under Education and Health.
What CFDA number is associated with this opportunity?
The summary associates the opportunity with CFDA number 93.279 (also referenced as 93.279 in the listing).
Does the summary provide an award ceiling or the expected number of awards?
No. The posted summary does not provide an award ceiling or an expected number of awards.
What does the use of the R21 mechanism suggest about project scope?
Even without specific award figures in the summary, an R21 generally signals a smaller, time-limited project aimed at proof-of-concept and feasibility data, rather than funding a full-scale clinical trial.
In one sentence, what is this FOA trying to achieve?
It is a targeted call for practical, patient-friendly biological measurement tools that reduce invasiveness and logistical burden while improving objective, clinically relevant data collection in outpatient medication trials for substance use disorders.
Browse more opportunities from the same category: Education, Health
Next opportunity: Strengthening Local Capacity to Provide Sustainable HIV-Related Care and Treatment Services in South Africa under PEPFAR
Previous opportunity: Meeting PEPFAR’s accelerated targets for HIV in Mozambique under the President's Emergency Plan for AIDS Relief (PEPFAR)
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 PA 16 075
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PA 16 075) also looked into and applied for these:
| Funding Opportunity |
|---|
| Behavioral and Integrative Treatment Development Program (R34) Apply for PA 16 073 Funding Number: PA 16 073 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $225,000 |
| Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01) Apply for PA 16 076 Funding Number: PA 16 076 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $500,000 |
| Behavioral Science Track Award for Rapid Transition (B/Start)(R03) Apply for PAR 16 071 Funding Number: PAR 16 071 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $75,000 |
| Behavioral and Integrative Treatment Development Program (R01) Apply for PA 16 072 Funding Number: PA 16 072 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Feasibility Studies to Build Collaborative Partnerships in Cancer Research (P20) Apply for PAR 16 084 Funding Number: PAR 16 084 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $275,000 |
| Supplements to Promote Clinical Research Studies on Pediatric Burkitt Lymphoma in Low- and Middle-Income Countries (Admin Supp) Apply for PA 16 086 Funding Number: PA 16 086 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $100,000 |
| Imaging and Biomarkers for Early Cancer Detection (U01) Apply for PAR 16 089 Funding Number: PAR 16 089 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| SBIR Phase II Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics toward Commercialization (R44) Apply for RFA CA 16 008 Funding Number: RFA CA 16 008 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $1,000,000 |
| Cancer Tissue Engineering Collaborative: Enabling Biomimetic Tissue-Engineered Technologies for Cancer Research (U01) Apply for PAR 16 105 Funding Number: PAR 16 105 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $400,000 |
| Services Planning Research in the Appalachian Region to Address Adverse Health Consequences Associated with Increased Opioid Injection Drug Use (R03) Apply for RFA DA 16 015 Funding Number: RFA DA 16 015 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $100,000 |
| Cooperative Agreement to Develop Targeted Agents for Use with Systemic Agents Plus Radiotherapy (U01) Apply for PAR 16 111 Funding Number: PAR 16 111 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $450,000 |
| Increased Knowledge and Innovative Strategies to Reduce HIV Incidence-iKnow Projects (R01) Apply for PAR 16 117 Funding Number: PAR 16 117 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Physical Activity and Weight Control Interventions Among Cancer Survivors: Effects on Biomarkers of Prognosis and Survival (R21) Apply for PAR 16 123 Funding Number: PAR 16 123 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $200,000 |
| NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3) Apply for RFA DA 17 015 Funding Number: RFA DA 17 015 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $1,000,000 |
| Physical Activity and Weight Control Interventions Among Cancer Survivors: Effects on Biomarkers of Prognosis and Survival (R01) Apply for PAR 16 122 Funding Number: PAR 16 122 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| The Application of Big Data Analytics to Drug Abuse Research (R01) Apply for PA 16 119 Funding Number: PA 16 119 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Emerging Questions in Cancer Systems Biology (U01) Apply for PAR 16 131 Funding Number: PAR 16 131 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Cancer Research Education Grants Program to Promote Diversity - Research Experiences (R25) Apply for PAR 16 138 Funding Number: PAR 16 138 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $300,000 |
| The Early Detection Research Network: Biomarker Developmental Laboratories (U01) Apply for RFA CA 16 009 Funding Number: RFA CA 16 009 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Coordinating Center for Barrett's Esophagus Translational Research Network (BETRNet)(U24) Apply for RFA CA 16 007 Funding Number: RFA CA 16 007 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $250,000 |
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 "PA 16 075", 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.