Opportunity Information: Apply for RFA DA 11 015
Apply for RFA DA 11 015
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Medication Initiative for Tobacco Dependence (MITD) A New Product Development Partnership (PDP)(UH2/UH3)" 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 Feb 22, 2011 and posted on Feb 22, 2011.
- Applicants must submit their applications by Apr 26, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Special district governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) County governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Private 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 For profit organizations other than small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 Foreign (non U.S.) components of U.S. Organizations are allowed
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Opportunity Summary:
The Medication Initiative for Tobacco Dependence (MITD) opportunity (RFA-DA-11-015) is a National Institutes of Health cooperative agreement led by the National Institute on Drug Abuse (NIDA) to launch a new public-private partnership focused on developing medications for tobacco dependence. The central idea is to bring together nonprofit, private, and academic capabilities in a structured partnership model so that promising science can be moved more deliberately through the drug discovery and development pathway, with the end goal of producing safe and effective treatments for tobacco dependence, including smoking cessation aids.
The award uses a two-stage UH2/UH3 structure. The first stage (UH2) is a one-year planning phase designed to support a systematic, evidence-driven assessment of opportunities and gaps in tobacco dependence medication development. In practical terms, this phase is meant to clarify which scientific and development strategies are most promising, what assets and expertise are needed, and how a formal partnership should be organized to execute a development program. The UH2 period is not positioned as a full development program on its own; instead, it is intended to produce a coherent plan and operational framework for a Product Development Partnership (PDP), including the research agenda, governance approach, and the collaboration model required to work effectively across sectors.
The second stage (UH3) is the implementation and execution phase. Under UH3, the partnership is expected to function as an active PDP running a portfolio of research and development projects. A key feature is that one selected recipient takes on the role of the PDP Managing Partner, meaning that awardee would coordinate and drive day-to-day execution, align collaborators, and manage the work needed to advance candidate therapies. The UH3 work is explicitly oriented toward meeting regulatory expectations for eventual approval to market in the United States, which signals an emphasis on translational and development activities that go beyond basic research. This can include coordinated preclinical and clinical development planning, studies that support safety and efficacy determinations, and other development tasks commonly required to assemble a package suitable for regulatory review.
Administratively, this is a discretionary funding opportunity using the cooperative agreement mechanism, which generally indicates substantial federal scientific or programmatic involvement compared to a standard grant. The program is categorized under Education/Health and is associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs). There is no cost sharing or matching requirement stated for applicants, lowering barriers for organizations that might not be able to contribute significant non-federal funds.
Eligibility is broad and intentionally inclusive to support a true partnership ecosystem. Eligible applicants include a wide range of government entities (state, county, city/township, special districts, public housing authorities), public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), tribal governments and tribal organizations, and various mission-based or underserved-serving institutions (such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities). The announcement also allows non-U.S. entities and foreign components of U.S. organizations, indicating NIDA was open to incorporating international expertise where it adds value to the development effort.
Key timing information reflects that the announcement was posted and created on February 22, 2011, with an application closing date of April 26, 2011, and an archive date of May 27, 2011. The funding opportunity number is RFA-DA-11-015, and the full announcement was hosted through the NIH grants guide. Contact information in the notice points applicants to the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues, emphasizing that this listing is a summarized entry connected to a longer formal solicitation document.
Overall, MITD is best understood as an organized attempt by NIDA to stand up a medication-focused product development partnership for tobacco dependence, beginning with a structured planning year and transitioning into an execution phase where the partnership runs concrete development projects with a clear line of sight to U.S. regulatory approval and eventual public health impact.
FAQs: Medication Initiative for Tobacco Dependence (MITD) - RFA-DA-11-015
What is the Medication Initiative for Tobacco Dependence (MITD)?
MITD is a National Institutes of Health (NIH) cooperative agreement opportunity led by the National Institute on Drug Abuse (NIDA) to launch a new public-private partnership focused on developing medications for tobacco dependence, including smoking cessation aids.
What is the main goal of this opportunity?
The goal is to move promising science more deliberately through the drug discovery and development pathway and ultimately produce safe and effective treatments for tobacco dependence, with a clear line of sight to U.S. regulatory expectations for eventual approval to market.
What does “public-private partnership” mean in this program?
In this context, it means a structured partnership model that brings together nonprofit, private-sector, and academic capabilities so that development work can be coordinated across sectors instead of happening in isolation.
What funding mechanism does MITD use?
MITD uses the cooperative agreement mechanism, which generally indicates substantial federal scientific or programmatic involvement compared to a standard grant.
What is the funding opportunity number for MITD?
The funding opportunity number is RFA-DA-11-015.
Which NIH institute is leading this opportunity?
The opportunity is led by NIDA (National Institute on Drug Abuse), which is part of NIH.
What is the program’s structure (UH2/UH3)?
The award uses a two-stage UH2/UH3 structure: a first-stage UH2 planning phase followed by a second-stage UH3 implementation and execution phase.
What happens during the UH2 phase?
UH2 is a one-year planning phase intended to support a systematic, evidence-driven assessment of opportunities and gaps in tobacco dependence medication development. This phase is meant to clarify promising scientific and development strategies, identify required assets and expertise, and define how the partnership should be organized.
Is the UH2 phase a full drug development program?
No. The UH2 period is not positioned as a full development program on its own. It is intended to produce a coherent plan and operational framework for a Product Development Partnership (PDP).
What is expected to be produced by the end of the UH2 phase?
By the end of UH2, the effort is expected to yield a plan and operational framework for a PDP, including a research agenda, a governance approach, and a collaboration model that supports effective cross-sector work.
What happens during the UH3 phase?
UH3 is the implementation and execution phase. The partnership is expected to operate as an active Product Development Partnership running a portfolio of research and development projects to advance candidate therapies.
What is a Product Development Partnership (PDP) in this opportunity?
A PDP here refers to an organized partnership designed to manage and execute a coordinated set (portfolio) of research and development activities aimed at developing tobacco dependence medications.
What is the “PDP Managing Partner” role?
Under UH3, one selected recipient is expected to serve as the PDP Managing Partner. That awardee would coordinate and drive day-to-day execution, align collaborators, and manage the work needed to advance candidate therapies.
What types of activities can be included under UH3?
UH3 activities can include coordinated preclinical and clinical development planning, studies supporting safety and efficacy determinations, and other development tasks commonly required to assemble a package suitable for regulatory review.
Is this opportunity oriented toward basic research or development work?
Based on the description, it is oriented toward translational and development activities that go beyond basic research, with explicit attention to regulatory expectations for eventual U.S. market approval.
Does the opportunity mention regulatory expectations?
Yes. UH3 work is explicitly oriented toward meeting regulatory expectations for eventual approval to market in the United States.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for applicants.
What program category is this opportunity associated with?
The opportunity is categorized under Education/Health.
What CFDA number is associated with this program?
The program is associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs).
Who is eligible to apply?
Eligibility is broad and includes many entity types: state, county, city/township, and special district governments; public housing authorities; public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including small businesses and other for-profits); tribal governments and tribal organizations; and other mission-based or underserved-serving institutions.
Are institutions like HBCUs and Hispanic-serving institutions eligible?
Yes. The eligibility description explicitly includes HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities (among others).
Are non-U.S. organizations or foreign components allowed?
Yes. The announcement allows non-U.S. entities and foreign components of U.S. organizations, indicating openness to international expertise where it adds value to the development effort.
When was this opportunity posted and what were the key dates?
The announcement was posted/created on February 22, 2011. The application closing date was April 26, 2011. The archive date was May 27, 2011.
Where was the full announcement hosted?
The full announcement was hosted through the NIH grants guide.
What contact is provided for technical issues with the listing?
Contact information points applicants to the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.
What is the overall purpose of MITD in plain terms?
It is an organized attempt by NIDA to stand up a medication-focused product development partnership for tobacco dependence, starting with a structured planning year and then transitioning into a phase where the partnership runs concrete development projects intended to lead toward eventual U.S. regulatory approval and public health impact.
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