Opportunity Information: Apply for PA 07 366
Apply for PA 07 366
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Medications Development for the Treatment of Cannabis Related 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 Dec 5, 2008 and posted on Apr 25, 2007.
- Applicants must submit their applications by Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses County governments For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments 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) Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized).
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
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Opportunity Summary:
The Medications Development for the Treatment of Cannabis Related Disorders (R21) funding opportunity (PA-07-366) is a National Institutes of Health grant announcement, led by the National Institute on Drug Abuse (NIDA), focused on jump starting early-stage research that can lead to new medications for cannabis-related clinical problems. The core aim is to support exploratory and developmental projects that identify, evaluate, and advance safe and effective pharmacological treatments for Cannabis Related Disorders (CRDs) and the medical or psychiatric consequences that often come along with them. This includes work spanning both preclinical and clinical research, meaning applicants can propose laboratory, animal-model, human laboratory, or early clinical study approaches as long as the project is geared toward medications development.
From a clinical scope standpoint, the FOA is broad and intentionally inclusive. It covers Cannabis Use Disorders (CUDs), such as cannabis abuse and dependence, and Cannabis Induced Disorders (CIDs), such as cannabis intoxication and cannabis-induced psychiatric symptoms like psychosis and anxiety. It also explicitly calls out the need to address comorbidity, recognizing that cannabis problems frequently overlap with other medical and psychiatric disorders, with depression given as an example. Importantly, the announcement defines cannabis use to include marijuana, hashish, and other substances containing tetrahydrocannabinol (THC), so the target population and exposure types are not limited to one product form.
NIDA explains the public health rationale in straightforward terms: marijuana use is highly prevalent, perceptions of risk have been trending downward, and there is limited research relative to the scale of use and the potential harms. The agency also emphasizes a major gap in care: there are no effective pharmacological treatments currently available for these cannabis-related disorders. This FOA is positioned as a way to generate the kind of early evidence needed to move candidate medications forward, potentially setting the stage for larger confirmatory trials or more advanced development work later on.
The funding mechanism is the NIH Exploratory/Developmental R21 award. In practice, that signals support for novel, potentially high-impact ideas that may still be at an early proof-of-concept stage rather than fully mature programs of research. The FOA is described as running in parallel with an R01 version of the same scientific scope (PA-07-365), which matters because it gives applicants a choice between a shorter, exploratory R21 pathway and a more extensive R01 pathway depending on how developed their data and plans are.
Budget and timing constraints are clearly defined. The maximum project period is two years, and the direct cost cap is $275,000 total across those two years, with an additional restriction that no single year may exceed $200,000 in direct costs. The R21 under this announcement is not renewable, which reinforces that the agency expects a tightly scoped project that produces a clear early deliverable (for example, feasibility, safety/tolerability signals, target engagement, or an initial efficacy signal) rather than a long multi-stage program under the same award.
Eligibility is broad across many organization types. Eligible applicants include public and private institutions of higher education, nonprofits both with and without 501(c)(3) status, small businesses, and for-profit organizations (other than small businesses), as well as state governments, U.S. territories or possessions, and a wide range of tribal entities and tribally designated organizations. The FOA also allows foreign (non-U.S.) organizations to apply, and it states that eligible federal agencies may apply as well. Faith-based and community-based organizations are also eligible, which can be particularly relevant for clinical recruitment, community partnerships, or service-linked research settings. The listing additionally highlights various institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian serving institutions.
For leadership eligibility, the FOA keeps the standard NIH approach: any individual with the expertise, resources, and institutional backing to carry out the research can serve as Project Director/Principal Investigator. It also reiterates NIH-wide encouragement for applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities, emphasizing inclusivity in who leads this work.
Submission rules are also spelled out in a practical way. Applicants may submit more than one application as long as each is scientifically distinct, which is helpful for groups with multiple medication candidates, multiple mechanistic hypotheses, or different populations or endpoints they want to pursue separately. Competing renewals are not accepted for this R21 mechanism, consistent with the non-renewable nature of R21s. However, the FOA allows up to two resubmissions of a previously reviewed R21 application, giving applicants a defined pathway to revise and improve an application based on reviewer feedback.
Administratively, this is a discretionary grant program with CFDA number 93.279 (Drug Abuse and Addiction Research Programs), and it does not require cost sharing or matching. The announcement was originally posted April 25, 2007, and it used multiple receipt dates rather than a single deadline, meaning applications were accepted on scheduled recurring NIH due dates during the active period of the FOA. The archived date listed is June 7, 2010, which signals that this specific announcement is no longer active, though similar opportunities may exist under newer FOAs.
In short, PA-07-366 is designed to fund short, focused R21 projects that can rapidly generate early evidence toward medications for cannabis use disorder, cannabis-induced conditions (including psychiatric effects), and cannabis-related comorbidities, with a strong emphasis on addressing a recognized treatment gap and supporting both preclinical and clinical steps that move medication candidates closer to real-world therapeutic options.
Frequently Asked Questions (FAQs): Medications Development for the Treatment of Cannabis Related Disorders (R21) - PA-07-366
What is PA-07-366?
PA-07-366 is a National Institutes of Health (NIH) funding opportunity announcement for an R21 Exploratory/Developmental grant focused on medications development for Cannabis Related Disorders (CRDs). It is led by the National Institute on Drug Abuse (NIDA).
What is the main purpose of this funding opportunity?
The purpose is to jump start early-stage research that can lead to new, safe, and effective pharmacological treatments for cannabis-related clinical problems, including cannabis use disorders, cannabis-induced disorders, and associated medical or psychiatric consequences.
What types of projects does the R21 mechanism support under this FOA?
This FOA supports exploratory and developmental projects that identify, evaluate, and advance candidate medications. Projects can be early proof-of-concept and are generally expected to produce an early, clearly defined deliverable rather than a long multi-stage program of research.
Does the FOA allow both preclinical and clinical research?
Yes. Applicants may propose preclinical and/or clinical approaches, including laboratory studies, animal-model work, human laboratory studies, or early clinical studies, as long as the work is geared toward medications development for cannabis-related disorders and consequences.
Which cannabis-related conditions are within the clinical scope?
The scope is broad and includes Cannabis Use Disorders (CUDs) such as cannabis abuse and dependence, as well as Cannabis Induced Disorders (CIDs) such as cannabis intoxication and cannabis-induced psychiatric symptoms (including examples like psychosis and anxiety).
Does the FOA address co-occurring (comorbid) conditions?
Yes. The FOA explicitly recognizes comorbidity and notes that cannabis problems often overlap with other medical and psychiatric disorders, providing depression as an example.
How does the FOA define "cannabis use" for the purposes of this research?
The announcement defines cannabis use to include marijuana, hashish, and other substances containing tetrahydrocannabinol (THC). The target exposure is not limited to a single product form.
Why did NIDA describe this as a public health priority?
NIDA cites high prevalence of marijuana use, declining perceptions of risk, and limited research relative to the scale of use and potential harms. The FOA also highlights a major treatment gap: no effective pharmacological treatments were available for cannabis-related disorders at the time of the announcement.
What is the grant mechanism and why does it matter?
The mechanism is the NIH Exploratory/Developmental R21 award. This mechanism typically supports novel and potentially high-impact ideas that are still at an early stage, rather than fully mature research programs.
Is there an R01 version of this same scientific scope?
Yes. The FOA is described as running in parallel with an R01 version with the same scientific scope (PA-07-365). This provides an option depending on whether an applicant is pursuing a shorter exploratory pathway (R21) or a more extensive project (R01).
What is the maximum project period?
The maximum project period is two years.
What is the maximum budget allowed?
The direct cost cap is $275,000 total across the two-year project period, with an additional restriction that no single year may exceed $200,000 in direct costs.
Is the R21 under this FOA renewable?
No. This R21 is not renewable, consistent with the expectation that the award supports a tightly scoped project designed to generate early evidence.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
What kinds of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits with and without 501(c)(3) status, small businesses, for-profit organizations (other than small businesses), state governments, U.S. territories or possessions, and a wide range of tribal entities and tribally designated organizations.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA allows foreign organizations to apply.
Can federal agencies apply?
Yes. The FOA states that eligible federal agencies may apply.
Are faith-based and community-based organizations eligible?
Yes. The FOA explicitly indicates that faith-based and community-based organizations are eligible.
Does the FOA highlight any specific institution types?
Yes. The listing highlights institution types including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian serving institutions.
Who can serve as the Project Director/Principal Investigator (PD/PI)?
Any individual with the expertise, resources, and institutional backing to carry out the proposed research may serve as PD/PI, consistent with the standard NIH approach described in the FOA.
Does NIH encourage applications from underrepresented groups?
Yes. The FOA reiterates NIH-wide encouragement for applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities.
Can an applicant submit more than one application to this FOA?
Yes. Applicants may submit more than one application as long as each application is scientifically distinct.
Are competing renewals allowed for this R21?
No. Competing renewals are not accepted for this R21 mechanism.
Are resubmissions allowed?
Yes. The FOA allows up to two resubmissions of a previously reviewed R21 application.
What is the CFDA number associated with this program?
The CFDA number is 93.279 (Drug Abuse and Addiction Research Programs).
Is this funding opportunity still active?
No. The archived date listed is June 7, 2010, indicating that this specific announcement is no longer active, although similar opportunities may exist under newer funding announcements.
When was the announcement originally posted?
The announcement was originally posted on April 25, 2007.
Did the FOA use a single deadline or recurring receipt dates?
It used multiple receipt dates rather than a single deadline, meaning applications were accepted on scheduled recurring NIH due dates during the active period of the FOA.
What kind of outcomes or deliverables does the FOA implicitly emphasize for an R21?
Because the award is short (two years) and non-renewable, the FOA frames the R21 as a way to generate early evidence that can move candidate medications forward, such as feasibility results, safety/tolerability signals, target engagement, or an initial efficacy signal.
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Previous opportunity: Medications Development for the Treatment of Cannabis Related Disorders (R01)
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