Opportunity Information: Apply for PAR 12 238
Apply for PAR 12 238
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "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 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on Aug 6, 2015 and posted on Jul 16, 2012.
- Applicants must submit their applications by Jan 7, 2016. (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 $200,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal governments (Federally recognized) City or township governments Private institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses State governments Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply.Non domestic (non U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) released this Funding Opportunity Announcement, PAR-12-238, to support early-stage, exploratory projects under the R21 mechanism focused on improving how outpatient clinical trials measure drug use in people being treated for Substance Use Disorders (SUDs). The core idea is to move beyond clinic-only testing and develop practical bioassay approaches that can be used repeatedly and conveniently outside of a research site, while still producing objective data that a clinical trial can rely on. This is especially important for outpatient pharmacotherapy trials, where participants live in the community and drug use patterns may fluctuate between scheduled visits, making it harder to accurately determine whether a medication is reducing use.
The scientific focus is on creating non-invasive or minimally invasive sampling and testing methods. The FOA explicitly mentions non-invasive matrices such as urine, sweat, and oral fluids, and also allows minimally invasive collection like fingerstick blood sampling. NIDA is looking for devices, assays, or integrated techniques that can better estimate both the quantity and frequency of an abused drug consumed during a trial, not just whether any use occurred. In practical terms, the opportunity is aimed at tools that can more accurately reconstruct drug exposure over time, helping trial teams understand changes in use patterns that fall short of complete abstinence. That matters because many medications may meaningfully reduce use (for example, fewer days of use, smaller amounts, or lower systemic exposure) even when participants do not achieve total cessation, and the trial needs credible measures to detect those improvements.
A key performance expectation is the ability to assess systemic drug levels in a way that supports rigorous trial outcomes. The FOA emphasizes solutions that are safe, portable, affordable, and simple enough for participants to collect multiple samples at home. The envisioned workflow is that participants can self-collect or minimally self-collect repeated samples over time and then bring or send them back to the clinic for batch analysis, which can reduce burden, lower costs, and improve the time-resolution of drug-use measurement compared with infrequent in-clinic testing. Overall, the announcement is pushing toward methods that increase objectivity and data quality in outpatient settings while remaining realistic for real-world trial participants.
Administratively, this is a discretionary grant opportunity using the NIH Exploratory/Developmental Research Project Grant (R21) mechanism, with an award ceiling listed at $200,000 and no cost-sharing or matching requirement. The program falls under CFDA 93.279 (Drug Abuse and Addiction Research Programs). The FOA was posted July 16, 2012, with later administrative dates shown in the record, and the archived closing timeline indicates an original closing date of September 7, 2015, a current closing date of January 7, 2016, and an archive date of February 8, 2016, meaning it is no longer open as written but remains a useful reference point for the type of research NIDA has sought in this area.
Eligibility is broad and includes for-profit organizations (other than small businesses), small businesses, nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, and a wide range of government entities (state, county, city/township, special district), as well as public housing authorities/Indian housing authorities. The FOA also specifies eligibility for numerous institution types and community-based organizations, including faith-based and community-based organizations, HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, tribally controlled colleges and universities, and tribal governments and organizations (including those other than federally recognized, as noted). Foreign institutions are eligible to apply, non-U.S. components of U.S. organizations may apply, and foreign components are allowed consistent with NIH policy definitions, which signals an openness to international technical expertise in assay development as long as the application meets NIH requirements.
For full details, the official NIH guide notice and full FOA text were linked at http://grants.nih.gov/grants/guide/pa-files/PAR-12-238.html, and the listing provides NIH Office of Extramural Research (OER) webmaster contact information for access or linking problems.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is an NIH/NIDA Funding Opportunity Announcement (FOA) titled PAR-12-238. It supports early-stage, exploratory research projects under the NIH Exploratory/Developmental Research Project Grant (R21) mechanism, focused on improving how outpatient clinical trials measure drug use among people being treated for Substance Use Disorders (SUDs).
Which NIH institute is sponsoring this FOA?
The sponsoring institute is the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH).
What is the main problem this FOA is trying to solve?
The FOA targets limitations of clinic-only drug testing in outpatient clinical trials. Because participants live in the community and drug use may fluctuate between scheduled clinic visits, infrequent in-clinic testing can miss important changes in use. The FOA encourages approaches that provide more objective, reliable measurement of drug use over time in real-world outpatient settings.
What is the overall scientific goal of the projects supported under this FOA?
The goal is to develop practical bioassay approaches that can be used repeatedly and conveniently outside of a research site, while still producing objective data that outpatient clinical trials can rely on for rigorous outcomes.
What type of clinical trials are emphasized?
The FOA particularly emphasizes outpatient pharmacotherapy trials for SUDs, where measuring medication-related reductions in drug use can be difficult if measurement is limited to scheduled clinic visits.
What kinds of technologies or products does NIDA want applicants to develop?
NIDA is looking for devices, assays, or integrated techniques that improve measurement of drug use in outpatient trial participants. The emphasis is on approaches that can be used repeatedly outside the clinic and still provide objective, trial-relevant data.
Does the FOA focus only on detecting whether drug use happened?
No. A central focus is improving the ability to estimate both the quantity and frequency of an abused drug consumed during a trial, not merely the presence or absence of drug use.
Why does the FOA care about measuring quantity and frequency, not just abstinence?
The FOA highlights that many medications may produce meaningful reductions in drug use (such as fewer days of use, smaller amounts, or lower systemic exposure) even when participants do not achieve complete abstinence. Credible measures are needed to detect these improvements and interpret trial outcomes accurately.
What sample types (biological matrices) are specifically mentioned?
The FOA explicitly mentions non-invasive matrices such as urine, sweat, and oral fluids. It also allows minimally invasive collection methods, including fingerstick blood sampling.
Are invasive sampling methods required?
No. The scientific focus is on non-invasive or minimally invasive sampling and testing methods, with examples including urine, sweat, oral fluids, and fingerstick blood collection.
What does the FOA say about measuring systemic drug levels?
A key performance expectation is the ability to assess systemic drug levels in a way that supports rigorous clinical trial outcomes.
What practical features are expected from the proposed approach?
The FOA emphasizes solutions that are safe, portable, affordable, and simple enough for participants to collect multiple samples at home.
How does NIDA envision participants using these approaches during a trial?
The envisioned workflow is that participants self-collect or minimally self-collect repeated samples over time at home, and then bring or send the samples back to the clinic for batch analysis.
Why is the FOA interested in repeated at-home collection?
Repeated at-home collection can improve the time-resolution of drug-use measurement compared with infrequent in-clinic testing. It can also reduce participant burden, lower costs, and improve objectivity and data quality in outpatient settings.
What grant mechanism is used for this opportunity?
This opportunity uses the NIH Exploratory/Developmental Research Project Grant (R21) mechanism.
Is this a discretionary grant program?
Yes. The listing describes it as a discretionary grant opportunity.
What is the award ceiling stated in the listing?
The award ceiling listed is $200,000.
Is cost sharing or matching required?
No. The listing states there is no cost-sharing or matching requirement.
What is the CFDA number associated with this program?
The program is listed under CFDA 93.279, Drug Abuse and Addiction Research Programs.
When was the FOA posted?
The FOA was posted on July 16, 2012.
Is this FOA currently open for applications?
No. The record indicates it is no longer open as written. The archived timeline shows an original closing date of September 7, 2015, a current closing date of January 7, 2016, and an archive date of February 8, 2016.
If it is archived, why might it still be useful?
Although it is closed, it remains a useful reference point for the type of research NIDA has sought in developing improved outpatient drug-use measurement tools for clinical trials.
Who is eligible to apply?
Eligibility is broad and includes for-profit organizations (other than small businesses), small businesses, nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, and many government entities (including state, county, city/township, special district), as well as public housing authorities/Indian housing authorities.
Are community-based and faith-based organizations eligible?
Yes. The FOA specifies eligibility for community-based organizations and includes faith-based and community-based organizations among the eligible institution types.
Are minority-serving institutions and tribal institutions included in eligibility?
Yes. The FOA lists multiple institution types, including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, tribally controlled colleges and universities, and tribal governments and organizations (including those other than federally recognized, as noted).
Are foreign institutions allowed to apply?
Yes. Foreign institutions are eligible to apply. The FOA also indicates that non-U.S. components of U.S. organizations may apply and that foreign components are allowed consistent with NIH policy definitions.
Where can applicants find the official FOA text?
The official NIH guide notice and full FOA text were linked at http://grants.nih.gov/grants/guide/pa-files/PAR-12-238.html.
Who is listed as the contact for access or linking problems?
The listing references NIH Office of Extramural Research (OER) webmaster contact information for access or linking problems.
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| Clinical Development of Minimally Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01) Apply for PAR 12 239 Funding Number: PAR 12 239 Agency: National Institutes of Health Category: Education Health Funding Amount: $500,000 |
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| NCI National Clinical Trials Network Network Group Operations Centers (U10) Apply for RFA CA 12 010 Funding Number: RFA CA 12 010 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI National Clinical Trials Network Network Group Statistics and Data Management Centers (U10) Apply for RFA CA 12 011 Funding Number: RFA CA 12 011 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI National Clinical Trials Network Network Group Integrated Translational Science Centers (U10) Apply for RFA CA 12 012 Funding Number: RFA CA 12 012 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI National Clinical Trials Network Network Lead Academic Participating Sites (U10) Apply for RFA CA 12 013 Funding Number: RFA CA 12 013 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Behavioral Science Track Award for Rapid Transition (B/START) (R03) Apply for PAR 12 251 Funding Number: PAR 12 251 Agency: National Institutes of Health Category: Education Health Funding Amount: $75,000 |
| SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics Toward Commercialization (R44) Apply for RFA CA 12 023 Funding Number: RFA CA 12 023 Agency: National Institutes of Health Category: Education Health Funding Amount: $1,000,000 |
| The Interplay of Substance Abuse and HIV 1 Infection on Glial Cell Function (R01) Apply for RFA DA 13 010 Funding Number: RFA DA 13 010 Agency: National Institutes of Health Category: Education Health Funding Amount: $500,000 |
| The Interplay of Substance Abuse and HIV 1 Infection on Glial Cell Function (R21) Apply for RFA DA 13 011 Funding Number: RFA DA 13 011 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
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| Examination of Survivorship Care Planning Efficacy and Impact R01 Apply for PA 12 275 Funding Number: PA 12 275 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| FY 2013 American Schools and Hospitals Abroad Program Apply for DRAFT APS ASHA 12 000001 Funding Number: DRAFT APS ASHA 12 000001 Agency: Agency for International Development Category: Education Health Funding Amount: $2,000,000 |
| HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R21) Apply for PA 12 280 Funding Number: PA 12 280 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R01) Apply for PA 12 281 Funding Number: PA 12 281 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| AIDS Science Track Award for Research Transition (R03) Apply for PA 12 282 Funding Number: PA 12 282 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Revisions for Early Stage Development of Informatics Technology (R01) Apply for PAR 12 286 Funding Number: PAR 12 286 Agency: National Institutes of Health Category: Education Health Funding Amount: $150,000 |
| Advanced Development of Informatics Technology (U24) Apply for PAR 12 287 Funding Number: PAR 12 287 Agency: National Institutes of Health Category: Education Health Funding Amount: $500,000 |
| Early Stage Development of Informatics Technology (U01) Apply for PAR 12 288 Funding Number: PAR 12 288 Agency: National Institutes of Health Category: Education Health Funding Amount: $250,000 |
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