Opportunity Information: Apply for PAR 12 239
Apply for PAR 12 239
- The National Institutes of Health 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 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on Aug 7, 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 $500,000.00 in funding.
- Eligible applicants include: Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Public housing authorities/Indian housing authorities City or township governments Native American tribal governments (Federally recognized) Small businesses County governments Public and State controlled institutions of higher education 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 State 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 NIH National Institute on Drug Abuse (NIDA) grant opportunity PAR-12-239 is a discretionary Research Project Grant (R01) focused on improving how outpatient clinical trials measure drug use while testing medications for Substance Use Disorders (SUDs). The core idea is that many outpatient trials still rely heavily on self-report or infrequent clinic-based testing, which can miss patterns of use and make it harder to tell whether a medication is helping. This FOA targets the development and clinical validation of bioassay approaches that are either noninvasive (for example, urine, sweat, or oral fluid testing) or minimally invasive (such as fingerstick blood sampling) so that drug exposure can be measured more objectively, more frequently, and with less burden on participants.
A central scientific goal of the announcement is to support tools that can estimate actual drug consumption in a way that goes beyond a simple positive/negative test. NIDA is emphasizing the need to capture both the quantity and frequency of drug intake during an outpatient medication trial. That matters because many promising treatments may reduce use without producing complete abstinence right away. If a trial can only classify participants as abstinent versus not abstinent, it may fail to detect meaningful improvements. The FOA therefore encourages methods that can translate biological samples into more informative measures of systemic drug levels over time, helping researchers quantify reductions in use and characterize patterns like intermittent versus sustained consumption.
Another major emphasis is practicality for real-world outpatient research. The FOA specifically points applicants toward devices or techniques that are safe, portable, affordable, and straightforward enough for participants to collect multiple samples at home. A key envisioned workflow is that participants can take repeated samples outside the clinic setting, then bring or send those samples back for batch analysis. This design aims to increase sampling frequency without requiring daily clinic visits, which is often unrealistic and expensive in outpatient trials. In effect, the grant is trying to bridge the gap between rigorous biological measurement and the logistical realities of outpatient SUD treatment studies.
From a funding and administrative standpoint, this is an NIH R01 mechanism under CFDA 93.279 (Drug Abuse and Addiction Research Programs), with an award ceiling listed at $500,000. The opportunity does not require cost sharing or matching, which aligns with typical NIH research grant structures. The FOA was posted July 16, 2012, with later administrative dates listed (creation date August 7, 2015), and it ultimately closed January 7, 2016, with an archive date of February 7, 2016. While those dates indicate the particular announcement is archived, the scientific priorities reflected in it describe the type of work NIDA sought to stimulate through that funding call.
Eligibility is broad and includes many categories of domestic and non-domestic applicants. Eligible applicants listed include federal, state, county, city/township, special district governments, and U.S. territory or possession entities; public and private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and other for-profits); public housing authorities/Indian housing authorities; independent school districts; and tribal governments and organizations, including federally recognized tribes and other tribal entities. The FOA also explicitly notes eligibility for Alaska Native and Native Hawaiian Serving Institutions, HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), regional organizations, and faith-based or community-based organizations. Foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components as defined in NIH policy are allowed, signaling that NIDA was open to international expertise and collaborations in bioassay and device development where relevant.
Overall, PAR-12-239 is aimed at advancing the measurement science needed for outpatient SUD pharmacotherapy trials. It is less about testing a specific medication and more about building and clinically developing the bioassay infrastructure that makes medication trials more informative: tools that can capture real changes in drug-taking behavior in a quantitative way, using sample collection approaches that participants can realistically carry out at home. The full announcement was made available through the NIH Grants Guide page associated with the FOA (http://grants.nih.gov/grants/guide/pa-files/PAR-12-239.html), and NIH’s Office of Extramural Research provided webmaster support contacts for access and linking issues.
Frequently Asked Questions (FAQs) - NIH/NIDA PAR-12-239 (R01)
What is PAR-12-239?
PAR-12-239 is a National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA) funding opportunity announcement (FOA) for a discretionary Research Project Grant (R01). It focuses on improving how outpatient clinical trials measure drug use while testing medications for Substance Use Disorders (SUDs).
What is the main purpose of this funding opportunity?
The FOA aims to support the development and clinical validation of bioassay approaches that can measure drug exposure more objectively, more frequently, and with less burden on participants in outpatient medication trials for SUDs.
Why is NIDA emphasizing improved drug-use measurement in outpatient trials?
Many outpatient trials rely heavily on self-report or infrequent clinic-based testing. Those approaches can miss patterns of drug use and make it harder to determine whether a medication is helping. PAR-12-239 targets methods that improve objectivity and sampling frequency while staying practical for outpatient research.
What kinds of measurement approaches does this FOA encourage?
The FOA encourages bioassay approaches that are noninvasive or minimally invasive, including examples such as urine, sweat, or oral fluid testing (noninvasive) and fingerstick blood sampling (minimally invasive).
What does "bioassay" mean in the context of this announcement?
In this FOA, a bioassay refers to a method that uses biological samples to assess drug exposure. The goal is to create tools that provide more informative measures of drug intake over time than a simple positive/negative result.
Is the FOA mainly about testing a new medication for SUDs?
No. The emphasis is less about testing a specific medication and more about building and clinically developing the bioassay infrastructure that makes outpatient SUD pharmacotherapy trials more informative.
What is the scientific goal regarding drug-use outcomes?
A central goal is to support tools that can estimate actual drug consumption in a way that goes beyond a binary positive/negative test. NIDA is emphasizing measurement of both quantity and frequency of drug intake during an outpatient medication trial.
Why does the FOA emphasize measuring quantity and frequency (not just abstinence)?
Many promising treatments may reduce use without producing complete abstinence right away. If a trial can only classify participants as abstinent versus not abstinent, it may fail to detect meaningful improvements. The FOA encourages measures that can quantify reductions in use and distinguish patterns like intermittent versus sustained consumption.
What kinds of drug-use patterns is this FOA interested in capturing?
The FOA highlights the importance of characterizing patterns such as intermittent versus sustained consumption, and tracking systemic drug levels over time to better understand changes in drug-taking behavior during outpatient trials.
How does this FOA address real-world outpatient trial logistics?
Practicality is a major emphasis. The FOA points applicants toward devices or techniques that are safe, portable, affordable, and straightforward enough for participants to collect multiple samples at home.
Does the FOA envision at-home sample collection by participants?
Yes. A key envisioned workflow is that participants can take repeated samples outside the clinic setting and then bring or send those samples back for batch analysis. This aims to increase sampling frequency without requiring daily clinic visits.
Why is increased sampling frequency important for outpatient medication trials?
More frequent sampling can reduce the chance of missing drug-use episodes and can improve the ability of a trial to detect changes over time, especially when self-report or infrequent clinic testing may not capture the full pattern of use.
What grant mechanism is used for PAR-12-239?
PAR-12-239 uses the NIH Research Project Grant (R01) mechanism.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.279, Drug Abuse and Addiction Research Programs.
What is the award ceiling listed for this FOA?
The award ceiling is listed at $500,000.
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching, consistent with typical NIH research grant structures.
Is this FOA still open for applications?
No. The FOA is archived. It was posted on July 16, 2012, ultimately closed on January 7, 2016, and has an archive date of February 7, 2016 (with an administrative creation date listed as August 7, 2015).
Even though it is archived, what does PAR-12-239 indicate about NIDA priorities?
While the specific announcement is closed, it reflects NIDA's interest in advancing measurement science for outpatient SUD pharmacotherapy trials, especially tools that can quantify real changes in drug-taking behavior using participant-friendly sample collection methods.
Who is eligible to apply?
Eligibility is broad and includes many categories of domestic and non-domestic applicants. Eligible applicants listed include various government entities, higher education institutions, nonprofits, for-profit organizations, housing authorities, school districts, tribal governments and organizations, and other specified institution types.
Are U.S. federal, state, and local government entities eligible?
Yes. The eligible applicant types include federal, state, county, city/township, and special district governments, as well as U.S. territory or possession entities.
Are colleges and universities eligible?
Yes. Both public and private institutions of higher education are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits are eligible, including both 501(c)(3) and non-501(c)(3) organizations.
Are for-profit organizations eligible?
Yes. For-profit organizations are eligible, including small businesses and other for-profit entities.
Are tribal governments and tribal organizations eligible?
Yes. Eligibility includes tribal governments and organizations, including federally recognized tribes and other tribal entities.
Does the FOA mention specific institution categories like HBCUs and Hispanic-serving institutions?
Yes. It explicitly notes eligibility for Alaska Native and Native Hawaiian Serving Institutions, HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), and regional organizations, as well as faith-based or community-based organizations.
Are foreign institutions eligible to apply?
Yes. Foreign institutions are eligible to apply according to the FOA description.
Are non-U.S. components of U.S. organizations eligible?
Yes. The FOA states that non-U.S. components of U.S. organizations are eligible.
Are foreign components allowed under NIH policy?
Yes. The FOA allows foreign components as defined in NIH policy.
Where can the full FOA be found?
The full announcement was made available through the NIH Grants Guide page associated with the FOA at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-239.html
Who provided support contacts for access or linking issues?
The information notes that NIH's Office of Extramural Research provided webmaster support contacts for access and linking issues.
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| Revisions for Early Stage Development of Informatics Technology (U01) Apply for PAR 12 289 Funding Number: PAR 12 289 Agency: National Institutes of Health Category: Education Health Funding Amount: $150,000 |
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