Opportunity Information: Apply for PA 16 076
Apply for PA 16 076
- 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 (R01)" 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.)
- Each selected applicant is eligible to receive up to $500,000.00 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).
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Opportunity Summary:
The funding opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01)" (Funding Opportunity Number PA-16-076) is a discretionary NIH research grant solicitation intended to strengthen the tools used in outpatient clinical trials for substance use disorder (SUD) medications. The central goal is to support the clinical development of minimally invasive or non-invasive bioassays that can be used to monitor, verify, or otherwise support evaluation of pharmacotherapies in real-world outpatient settings, where frequent in-clinic sampling can be impractical and where adherence, relapse detection, and objective outcome measurement can be harder to capture consistently.
This is an R01 Research Project Grant, meaning it is structured to fund a defined, hypothesis-driven or product-development-focused research plan that can produce a usable, clinically relevant method rather than only early exploratory work. The emphasis in the description is on methods that reduce invasiveness and improve feasibility for outpatient trials, which typically implies approaches such as saliva, breath, sweat, urine (often considered minimally invasive compared with blood draws depending on context), hair, wearable or patch-based sampling, or other low-burden collection strategies that can be deployed repeatedly over time. In practice, the bioassays supported under this type of announcement would be expected to improve objective measurement of drug exposure, medication adherence, substance use or abstinence, or relevant biomarkers that help interpret therapeutic response during clinical testing of SUD treatments.
The sponsoring agency is the U.S. Department of Health and Human Services, National Institutes of Health (listed as HHS-NIH11), and the program is associated with CFDA numbers 93.279 (and also 93.279 is listed alongside another entry in the source data). The opportunity category is discretionary, and the funding instrument is a grant within the broad activity area of education and health, consistent with NIH biomedical research support. The announcement was created and posted on January 8, 2016, and the listed closing date for applications in the source data is September 7, 2018.
Eligibility is broad and includes a wide range of public and private organizations. 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 as well as non-federally recognized tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and additional eligible entities as clarified in the full FOA text. This broad eligibility signals an intent to attract proposals from academic clinical researchers, hospital systems, public health entities, diagnostic developers, and commercial or translational groups capable of creating and clinically validating bioassay methods.
From the available data, the award ceiling is listed as $500,000. The number of expected awards is not specified in the provided source excerpt. Overall, the opportunity is geared toward improving the practical measurement infrastructure for outpatient SUD medication trials by funding development and clinical validation of bioassays that are easier to administer outside intensive inpatient or highly controlled research environments, thereby helping trials produce more reliable, objective, and scalable evidence about therapeutic effectiveness.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The funding opportunity is titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA-16-076.
What type of funding mechanism is this?
This opportunity uses the NIH R01 Research Project Grant mechanism. It is intended to support a defined research plan that is hypothesis-driven or focused on developing a clinically usable method, rather than only early exploratory work.
Which federal agency is sponsoring this opportunity?
The sponsoring agency is the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), listed as HHS-NIH11.
What is the main goal of this opportunity?
The central goal is to strengthen tools used in outpatient clinical trials of medications for substance use disorders (SUD) by supporting the clinical development of minimally invasive or non-invasive bioassays that can be used in real-world outpatient settings.
What problem is this grant trying to address in outpatient SUD trials?
Outpatient trials often cannot rely on frequent in-clinic sampling, and it can be difficult to consistently measure adherence, detect relapse, and capture objective outcomes. This opportunity focuses on developing bioassays that make monitoring and verification more feasible outside highly controlled environments.
What kinds of bioassays or sampling approaches are emphasized?
The description emphasizes minimally invasive or non-invasive approaches that reduce participant burden and can be deployed repeatedly over time. Examples implied by the opportunity include saliva, breath, sweat, urine (often considered minimally invasive depending on context), hair, wearable or patch-based sampling, and other low-burden collection strategies.
What are these bioassays expected to measure or support?
The supported bioassays are expected to improve objective measurement used in SUD pharmacotherapy trials, such as drug exposure, medication adherence, substance use or abstinence, or other relevant biomarkers that help interpret therapeutic response during clinical testing.
Is this opportunity focused on inpatient trials or outpatient trials?
It is specifically oriented toward outpatient clinical trials and real-world outpatient settings, where frequent in-clinic sampling is often impractical.
Is this considered a discretionary grant opportunity?
Yes. The opportunity category is listed as discretionary.
What is the funding instrument?
The funding instrument is a grant.
What activity area does this opportunity fall under?
The activity area is within education and health, consistent with NIH biomedical research support.
What CFDA number(s) are associated with this opportunity?
The program is associated with CFDA number 93.279 (and the source data also lists 93.279 alongside another entry).
Who is eligible to apply?
Eligibility is broad and includes many public and private organization types. 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
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Non-federally recognized Native American tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with 501(c)(3) status (excluding institutions of higher education in those nonprofit categories)
- Nonprofits without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories)
- For-profit organizations other than small businesses
- Small businesses
- Other eligible entities as clarified in the full FOA text
Does eligibility include for-profit organizations and small businesses?
Yes. The eligibility list includes for-profit organizations other than small businesses and also includes small businesses.
Does eligibility include tribal governments and tribal organizations?
Yes. Eligible applicants include federally recognized Native American tribal governments as well as non-federally recognized tribal organizations.
Does eligibility include colleges and universities?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Does eligibility include nonprofits?
Yes. Nonprofits with and without 501(c)(3) status are eligible, with the note that institutions of higher education are excluded from those nonprofit categories (because they are listed separately as eligible).
What is the maximum award amount (award ceiling)?
The award ceiling is listed as $500,000.
How many awards are expected?
The number of expected awards is not specified in the provided source excerpt.
When was this funding opportunity posted?
The announcement was created and posted on January 8, 2016.
What is the application closing date listed in the source data?
The listed closing date for applications in the source data is September 7, 2018.
What kinds of organizations is NIH trying to attract to apply?
Based on the broad eligibility and the focus on clinically usable bioassays, the opportunity is positioned to attract proposals from academic clinical researchers, hospital systems, public health entities, diagnostic developers, and commercial or translational groups capable of creating and clinically validating bioassay methods.
What does "minimally invasive" mean in the context of this opportunity?
In this context, "minimally invasive" refers to measurement methods that reduce the need for burdensome procedures like frequent blood draws and instead rely on lower-burden specimens or collection methods that can be repeated over time in outpatient settings (for example, saliva, breath, sweat, urine depending on context, hair, or wearable/patch-based approaches).
What does "clinical development" imply for the supported work?
The opportunity is aimed at developing and clinically validating bioassays so they are practical and clinically relevant for outpatient SUD medication trials, rather than focusing only on early-stage exploratory concepts.
How does this opportunity support evaluation of SUD pharmacotherapies?
By improving objective measurement tools (such as adherence verification, exposure assessment, relapse detection, and biomarker-based outcome support), the bioassays developed under this opportunity are intended to help outpatient SUD medication trials generate more reliable, objective, and scalable evidence about therapeutic effectiveness.
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Previous opportunity: Behavioral and Integrative Treatment Development Program (R34)
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Applicants also applied for:
Applicants who have applied for this opportunity (PA 16 076) also looked into and applied for these:
| Funding Opportunity |
|---|
| 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 |
| Cancer Research Education Grants Program to Promote Diversity - Courses for Skills Development (R25) Apply for PAR 16 139 Funding Number: PAR 16 139 Agency: HHS-NIH11 Category: Education, Health Funding Amount: Case Dependent |
| Research Centers for Barretts Esophagus Translational Research Network (BETRNet)(U54) Apply for RFA CA 16 006 Funding Number: RFA CA 16 006 Agency: HHS-NIH11 Category: Education, Health Funding Amount: $900,000 |
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