Opportunity Information: Apply for RFA DA 15 003
Apply for RFA DA 15 003
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Medications Development Centers of Excellence Cooperative Program (U54)" 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 Jan 31, 2014 and posted on Jan 31, 2014.
- Applicants must submit their applications by Apr 25, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) State governments Independent school districts Public and State controlled institutions of higher education City or township governments For profit organizations other than small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal governments (Federally recognized) Special district governments Private institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Medications Development Centers of Excellence Cooperative Program (U54) is a National Institutes of Health (NIH) funding opportunity designed to build and support a small number of specialized, collaborative research centers focused on advancing medications and biologics for substance use disorders (SUDs). The central purpose of the program is clinical research that moves candidate treatments forward by identifying promising compounds or biologics, evaluating them in humans, and generating the evidence needed to support safe and effective use for SUD treatment. The FOA makes it clear that the emphasis is on clinical development rather than basic discovery work, and it encourages centers to take on both repurposing or testing currently approved products as well as developing novel investigational agents.
This award uses the U54 Specialized Center Cooperative Agreement mechanism, which signals a center-based approach with multiple integrated components and substantial scientific involvement from the NIH compared with a traditional investigator-initiated grant. In practice, applicants are expected to propose a cohesive center structure that can manage and execute clinical studies efficiently, coordinate specialized expertise, and maintain the operational capabilities needed for clinical medication development. While the program is clinically driven, a center is allowed to include a translational research project when it directly strengthens the scientific rationale for the medication(s) being tested clinically. Any preclinical work is permitted only to the extent that it supports and justifies the clinical testing planned during the project period; preclinical studies that are not clearly tied to medications intended for clinical evaluation under the award would not align with the FOA’s intent.
The opportunity is identified as Funding Opportunity Number RFA-DA-15-003, titled "Medications Development Centers of Excellence Cooperative Program (U54)," and falls under the NIH activity area related to Drug Abuse and Addiction Research Programs (CFDA 93.279). It was posted on January 31, 2014, with an application due date of April 25, 2014, and an estimated total funding level of $3,000,000. NIH anticipated making approximately two awards under this announcement, indicating a highly competitive program aimed at supporting a limited number of high-capability centers with strong clinical development pipelines and infrastructure.
Eligibility is broad across U.S.-based organizations and governments, including public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses. The FOA also explicitly includes a range of mission- and community-focused institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, among others. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible; however, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which typically means limited, well-justified elements of the work can occur outside the U.S. under NIH rules.
Overall, this FOA is aimed at creating or strengthening dedicated center-level programs that can push SUD medication candidates through rigorous clinical evaluation, with tightly scoped translational or preclinical activities only when they directly support the planned clinical testing. The intended outcome is to accelerate the development of safe and effective pharmacologic and biologic treatments for substance use disorders by concentrating expertise, infrastructure, and coordinated project leadership within NIH-supported Centers of Excellence.
Frequently Asked Questions (FAQs)
1. What is the Medications Development Centers of Excellence Cooperative Program (U54)?
It is an NIH funding opportunity to build and support a small number of specialized, collaborative research centers focused on advancing medications and biologics for substance use disorders (SUDs). The program is designed to move candidate treatments forward through clinical research in humans and generate evidence needed to support safe and effective SUD treatment.
2. What is the main purpose of this funding opportunity?
The central purpose is clinical research that advances medication or biologic candidates for SUDs by identifying promising agents, evaluating them in humans, and producing the clinical evidence needed to support safe and effective use.
3. Is this opportunity focused on basic discovery science?
No. The emphasis is on clinical development rather than basic discovery work. Activities that do not directly support clinical evaluation of medications intended for testing under the award do not match the stated intent.
4. What kinds of treatments are centers encouraged to work on?
Centers are encouraged to take on both (a) repurposing or testing currently approved products and (b) developing novel investigational agents, as long as the work is oriented toward clinical evaluation for SUD treatment.
5. What does the U54 Specialized Center Cooperative Agreement mechanism mean?
It indicates a center-based approach with multiple integrated components and substantial scientific involvement from NIH compared with a traditional investigator-initiated grant. Applicants are expected to propose a cohesive center structure capable of efficiently managing and executing clinical studies and coordinating specialized expertise.
6. What kind of center structure is expected from applicants?
Applicants are expected to propose an integrated, cohesive center that can manage clinical studies efficiently, coordinate specialized expertise, and maintain the operational capabilities needed for clinical medication development.
7. Are translational research projects allowed within the center?
Yes. A translational research project is allowed when it directly strengthens the scientific rationale for the medication(s) being tested clinically as part of the center’s work.
8. Is preclinical research permitted under this FOA?
Yes, but only to the extent that it supports and justifies the clinical testing planned during the project period. Preclinical studies that are not clearly tied to medications intended for clinical evaluation under the award would not align with the FOA’s intent.
9. What is the Funding Opportunity Number and title?
The Funding Opportunity Number is RFA-DA-15-003. The title is "Medications Development Centers of Excellence Cooperative Program (U54)."
10. What NIH activity area or program classification is this associated with?
It falls under NIH’s Drug Abuse and Addiction Research Programs and is associated with CFDA 93.279.
11. When was this opportunity posted, and when were applications due?
It was posted on January 31, 2014. Applications were due April 25, 2014.
12. How much funding was expected to be available?
The estimated total funding level was $3,000,000.
13. How many awards did NIH anticipate making?
NIH anticipated making approximately two awards under this announcement, suggesting a highly competitive program supporting a limited number of centers.
14. Who is eligible to apply?
Eligibility is broad for U.S.-based organizations and governments, including public and private institutions of higher education; state and local governments; tribal governments and tribal organizations; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); small businesses; and for-profit organizations other than small businesses.
15. Are specific institution types explicitly included?
Yes. The FOA explicitly includes institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, among others.
16. Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
17. Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible under this opportunity.
18. Are any international activities allowed at all?
Yes, "foreign components" (as defined by the NIH Grants Policy Statement) are allowed. This typically means limited, well-justified elements of the work can occur outside the U.S. under NIH rules, even though foreign institutions and non-U.S. organizational components are not eligible to apply.
19. What is the overall goal or intended outcome of the program?
The goal is to accelerate development of safe and effective pharmacologic and biologic treatments for substance use disorders by concentrating expertise, infrastructure, and coordinated project leadership within NIH-supported Centers of Excellence.
20. How should applicants think about aligning their proposed work with the FOA’s intent?
Proposed activities should be tightly centered on clinical development and human evaluation of SUD medication/biologic candidates. Translational and preclinical work should be included only when it directly supports and justifies the planned clinical testing during the project period.
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