Opportunity Information: Apply for PA 09 106
Apply for PA 09 106
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Medications Development for the Treatment of Pregnant/Postpartum Women with Substance Related Disorders and/or In Utero Substance Exposed Neonates (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 Mar 3, 2009 and posted on Mar 3, 2009.
- Applicants must submit their applications by May 7, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal governments (Federally recognized) Independent school districts Public housing authorities/Indian housing authorities Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments For profit organizations other than small businesses County governments City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This funding opportunity, PA-09-106, is a National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) R01 research grant aimed at improving medication-based care for two closely connected populations: pregnant or postpartum women with substance related disorders (SRDs) and neonates who were exposed to substances in utero. The core intent is to stimulate research that can lead to safer and more effective pharmacological treatment options during pregnancy and the postpartum period, when medication decisions are especially complex because they can affect both the mother and the developing fetus or newborn. The FOA is positioned to support both early-stage and more advanced research that directly addresses the unique clinical, developmental, and safety challenges involved in treating substance use disorders in these populations.
Scientifically, the FOA emphasizes two main paths. First, it encourages the discovery and development of new pharmacotherapies specifically suited to pregnancy, postpartum, and early neonatal contexts. This can include new chemical entities as well as immunotherapies, reflecting an interest in innovative approaches rather than limiting applicants to existing medication classes. Second, it invites studies that repurpose or evaluate FDA-approved medications originally approved for other indications, with the goal of determining whether they can be safely and effectively used to treat SRDs in pregnant/postpartum women or substance-exposed neonates. In other words, applicants can propose de novo medication development strategies or more translational work that tests whether existing drugs might fill current treatment gaps, provided the research is designed to generate meaningful evidence on safety and efficacy for these specific populations.
From a research design standpoint, NIDA indicates it will consider both preclinical and clinical research. Preclinical work may focus on identifying candidate compounds, characterizing mechanisms of action, establishing preliminary safety signals, or developing dosing and formulation considerations relevant to pregnancy or neonatal physiology. Clinical research may include studies that assess maternal outcomes (such as substance use reduction, relapse prevention, retention in care, and maternal health), neonatal outcomes (such as withdrawal severity, growth and development indicators, or other clinically relevant endpoints), and the broader benefit-risk balance unique to pregnancy and postpartum settings. The overarching expectation is that projects will be oriented toward medication development or rigorous evaluation rather than purely observational descriptions of substance exposure or outcomes.
In terms of mechanism and positioning, this opportunity uses the NIH Research Project Grant (R01) mechanism, which generally supports more substantial, hypothesis-driven projects with a defined scope and sufficient preliminary justification. The FOA is explicitly noted as running in parallel with another announcement of the same scientific scope that uses the R21 Exploratory/Developmental mechanism (PA-09-107). Practically, that signals an intentional pipeline: projects that are earlier or higher-risk may fit the R21 pathway, while more mature programs of work, including later-stage preclinical packages or clinical trials with a stronger evidence base, may be more appropriate for the R01 mechanism.
Administratively, the opportunity is categorized as a discretionary grant under health-related funding (CFDA 93.279, Drug Abuse and Addiction Research Programs). There is no cost sharing or matching requirement, which lowers the barrier for applicants who may not have non-federal funds to contribute. Awards are explicitly contingent on the availability of funds and the receipt of a sufficient number of meritorious applications, meaning there is no guaranteed number of awards stated in the summary information provided, and competitiveness will depend on both application quality and budget conditions at the time of review.
Eligibility is broad and includes a wide mix of academic, governmental, nonprofit, and for-profit entities. Eligible applicants include public and private institutions of higher education, state and local governments (including county and city/township governments), independent school districts, special district governments, small businesses, other for-profit organizations, public housing authorities, and nonprofits both with and without 501(c)(3) status (with the standard NIH caveats). The FOA also highlights eligibility for a wide range of mission-driven and community-anchored institutions and organizations, including federally recognized and other tribal governments and tribal organizations, tribally controlled colleges and universities, historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). Federal agencies are also listed as eligible in the additional eligibility language. This breadth suggests NIDA is open to multidisciplinary and cross-sector approaches, including collaborations that can reach pregnant and postpartum populations through healthcare systems, community settings, and specialized maternal-child health networks.
Key dates indicate the FOA was posted and created on March 3, 2009, with an original closing date of May 7, 2012, and it was archived on June 7, 2012. While it is no longer open, the summary still provides a clear view of NIDA priorities at the time: accelerating medication development and evaluation for pregnant/postpartum women with SRDs and for infants affected by in utero exposure, with a strong emphasis on translating pharmacological science into safer, evidence-based interventions for real-world clinical use.
Frequently Asked Questions (FAQs)
What is funding opportunity PA-09-106?
PA-09-106 is a National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) research funding opportunity that uses the R01 (Research Project Grant) mechanism. It is focused on research to improve medication-based care for pregnant or postpartum women with substance related disorders (SRDs) and for neonates exposed to substances in utero.
What is the main purpose of this grant opportunity?
The central goal is to stimulate research that can lead to safer and more effective pharmacological treatment options during pregnancy and the postpartum period, when treatment decisions can affect both the mother and the developing fetus or newborn. The opportunity is intended to support work that addresses the unique clinical, developmental, and safety challenges of medication-based treatment in these populations.
Which populations are the focus of the research supported under this FOA?
This FOA targets two closely connected populations: (1) pregnant or postpartum women with substance related disorders (SRDs), and (2) neonates who were exposed to substances in utero.
What kinds of research topics does the FOA emphasize?
The FOA highlights two major scientific paths: developing new pharmacotherapies specifically suited to pregnancy, postpartum, and early neonatal contexts; and evaluating or repurposing FDA-approved medications (originally approved for other indications) to determine whether they can be used safely and effectively for SRDs in pregnant/postpartum women or substance-exposed neonates.
Does this opportunity support development of entirely new medications?
Yes. The FOA encourages discovery and development of new pharmacotherapies for pregnancy, postpartum, and early neonatal contexts. This can include new chemical entities as well as immunotherapies, indicating interest in innovative treatment approaches.
Can applicants propose research that repurposes existing FDA-approved drugs?
Yes. The FOA explicitly invites studies that repurpose or evaluate FDA-approved medications that were originally approved for other indications, as long as the goal is to generate meaningful evidence on safety and efficacy for pregnant/postpartum women with SRDs or for substance-exposed neonates.
Are both preclinical and clinical studies allowed under PA-09-106?
Yes. NIDA indicates it will consider both preclinical and clinical research. Preclinical work may focus on identifying candidate compounds, mechanisms of action, early safety signals, or dosing/formulation considerations relevant to pregnancy or neonatal physiology. Clinical research may evaluate maternal outcomes, neonatal outcomes, and overall benefit-risk considerations specific to pregnancy and postpartum settings.
What kinds of outcomes might clinical studies measure?
Clinical research may include maternal outcomes such as reduction in substance use, relapse prevention, retention in care, and maternal health. It may also include neonatal outcomes such as withdrawal severity, growth and development indicators, or other clinically relevant endpoints, alongside broader benefit-risk assessments.
Is purely observational research within scope for this FOA?
The FOA emphasizes that projects are expected to be oriented toward medication development or rigorous evaluation rather than purely observational descriptions of substance exposure or outcomes.
What grant mechanism is used for PA-09-106?
This opportunity uses the NIH Research Project Grant (R01) mechanism, which typically supports more substantial, hypothesis-driven projects with a defined scope and appropriate preliminary justification.
How is PA-09-106 related to PA-09-107?
PA-09-106 is noted as running in parallel with another announcement of the same scientific scope that uses the R21 Exploratory/Developmental mechanism (PA-09-107). The pairing suggests a pipeline in which earlier or higher-risk work may fit R21, while more mature programs of work may be better suited for R01.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.279, Drug Abuse and Addiction Research Programs.
Is cost sharing or matching required?
No. The summary information specifies that there is no cost sharing or matching requirement.
Are awards guaranteed under this funding opportunity?
No. Awards are stated to be contingent on the availability of funds and the receipt of a sufficient number of meritorious applications. The information provided does not specify a guaranteed number of awards.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include public and private institutions of higher education; state and local governments (including county and city/township governments); independent school districts; special district governments; small businesses; other for-profit organizations; public housing authorities; and nonprofit organizations with or without 501(c)(3) status (subject to standard NIH caveats).
Are tribal governments and tribal organizations eligible?
Yes. The FOA includes federally recognized tribal governments and other tribal governments, tribal organizations, and tribally controlled colleges and universities among eligible applicants.
Are minority-serving institutions eligible to apply?
Yes. The FOA highlights eligibility for historically Black colleges and universities (HBCUs), Hispanic-serving institutions, and Alaska Native and Native Hawaiian-serving institutions.
Are faith-based or community-based organizations eligible?
Yes. The FOA explicitly includes faith-based and community-based organizations in its eligibility language.
Can organizations in U.S. territories or possessions apply?
Yes. The FOA includes U.S. territories or possessions among eligible applicants.
Are foreign (non-U.S.) entities eligible to apply?
Yes. The eligibility language includes non-U.S. entities (foreign organizations).
Are federal agencies eligible to apply?
Yes. Federal agencies are listed as eligible in the additional eligibility language provided in the summary.
When was this FOA posted and when did it close?
The FOA was posted and created on March 3, 2009. The original closing date was May 7, 2012, and it was archived on June 7, 2012.
Is PA-09-106 currently open for applications?
No. Based on the dates provided, it was archived on June 7, 2012, and is no longer open.
What does the archived status imply for applicants today?
It means the announcement is no longer active for submission. The summary remains useful as a reference for the research priorities and scope NIDA emphasized at the time, but it does not represent an open application window.
What type of grant is this described as administratively?
It is categorized as a discretionary grant under health-related funding, associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs).
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