Opportunity Information: Apply for RFA DA 14 004

  • 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 Apr 26, 2013 and posted on Apr 26, 2013.
  • Applicants must submit their applications by Aug 15, 2013. (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.
  • Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
  • The number of recipients for this funding is limited to 2 candidate(s).
  • Eligible applicants include: Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than 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 Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) County governments Small businesses State governments Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification).
  • 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) grant opportunity, Funding Opportunity Number RFA-DA-14-004, was issued by the National Institutes of Health (NIH) to support a small number of specialized research centers focused on developing medications and biologics for substance use disorders (SUDs). The program is designed around the Medications Development Centers of Excellence (MDCE) concept, with a strong emphasis on clinical research that moves promising treatment candidates forward through identification, evaluation, and development. Projects can address either products that are already approved for other uses and could be repurposed for SUDs, or entirely new investigational candidates. In addition, centers may include a translational research component to strengthen the scientific rationale for selecting and testing specific medication candidates, helping connect preclinical or mechanistic evidence to well-justified clinical testing strategies.

This opportunity uses the Cooperative Agreement funding mechanism (U54), which typically indicates a more collaborative relationship between the award recipients and NIH compared with traditional research project grants. In practice, that usually means NIH program staff may have substantial involvement in shaping priorities, coordinating across sites, and ensuring that the overall program is aligned with federal research goals for medications development in addiction. The activity category is listed as Education/Health, and the CFDA (now commonly referred to as Assistance Listing) associated with the program is 93.279, Drug Abuse and Addiction Research Programs.

NIH expected to make 2 awards under this announcement, with an estimated total program funding level of about $3,000,000. The listed award ceiling was $1,000,000, indicating that individual awards were expected to be capped around that amount (generally per year, depending on the specific FOA terms). There was no cost sharing or matching requirement, meaning applicants were not required to commit non-federal funds as a condition of receiving an award.

Eligibility for the program was broad and included many types of domestic organizations across the academic, nonprofit, government, and private sectors. Eligible applicants included private and public institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (including small businesses and other for-profit entities), and multiple levels of government such as state, county, city/township, special district governments, and independent school districts. The eligibility list also explicitly included tribal governments (both federally recognized and other than federally recognized) and tribal organizations, as well as public housing authorities/Indian housing authorities. The FOA also highlighted inclusion of organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions were not eligible to apply, and non-U.S. components of U.S. organizations were not eligible. However, foreign components, as defined under the NIH Grants Policy Statement, were allowed, which typically means a U.S. applicant organization could include certain international elements if they fit NIH policy and were well-justified scientifically.

Key dates for the announcement show it was posted and created on April 26, 2013, with an original and current application closing date of August 15, 2013. The archive date was September 15, 2013, indicating the FOA is no longer active for new submissions under that solicitation. For official details, NIH provided an additional information link to the full announcement on the NIH grants website and included contact instructions through the NIH Office of Extramural Research (OER) web support for access or technical linking problems.

Overall, this FOA was aimed at building or supporting center-based programs capable of conducting coordinated, clinically focused medications development efforts for SUDs, potentially spanning candidate selection, translational justification, and clinical evaluation, with NIH involvement characteristic of the cooperative agreement model.

Frequently Asked Questions (FAQs)

What is the Medications Development Centers of Excellence Cooperative Program (U54)?

It is an NIH funding opportunity designed to support a small number of specialized research centers focused on developing medications and biologics for substance use disorders (SUDs). The program centers on the Medications Development Centers of Excellence (MDCE) concept, emphasizing clinical research that advances promising treatment candidates through identification, evaluation, and development.

What is the Funding Opportunity Number (FOA) for this grant?

The Funding Opportunity Number is RFA-DA-14-004.

Which federal agency issued this funding opportunity?

The opportunity was issued by the National Institutes of Health (NIH).

What kinds of research does this program emphasize?

The program places a strong emphasis on clinical research that moves promising medication or biologic candidates forward. It is intended to support coordinated, clinically focused medications development efforts for SUDs, potentially spanning candidate selection, translational justification, and clinical evaluation.

Does the program support repurposing existing drugs as well as developing new candidates?

Yes. Projects can address products that are already approved for other uses and could be repurposed for SUDs, as well as entirely new investigational candidates.

Can a center include a translational research component?

Yes. Centers may include a translational research component to strengthen the scientific rationale for selecting and testing specific medication candidates. This component can help connect preclinical or mechanistic evidence to well-justified clinical testing strategies.

What funding mechanism is used for this opportunity?

This opportunity uses the Cooperative Agreement funding mechanism (U54).

What does a Cooperative Agreement (U54) typically mean for how NIH interacts with awardees?

A U54 cooperative agreement typically indicates a more collaborative relationship between award recipients and NIH than a traditional research project grant. In practice, NIH program staff may have substantial involvement in shaping priorities, coordinating across sites, and ensuring the overall program aligns with federal research goals for medications development in addiction.

What is the activity category for this program?

The activity category is listed as Education/Health.

What is the CFDA/Assistance Listing number associated with this program?

The CFDA (now commonly referred to as the Assistance Listing) is 93.279, Drug Abuse and Addiction Research Programs.

How many awards did NIH expect to make under this announcement?

NIH expected to make 2 awards under this announcement.

What was the estimated total program funding level?

The estimated total program funding level was about $3,000,000.

What was the award ceiling for an individual award?

The listed award ceiling was $1,000,000, indicating individual awards were expected to be capped around that amount (generally per year, depending on the specific FOA terms).

Is cost sharing or matching required?

No. There was no cost sharing or matching requirement, meaning applicants were not required to commit non-federal funds as a condition of receiving an award.

What types of organizations were eligible to apply?

Eligibility was broad and included many types of domestic organizations across academic, nonprofit, government, and private sectors. Eligible applicants included private and public institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (including small businesses and other for-profit entities); and multiple levels of government (state, county, city/township, special district governments, and independent school districts).

Were tribal entities eligible to apply?

Yes. The eligibility list explicitly included tribal governments (both federally recognized and other than federally recognized) and tribal organizations.

Are public housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities were included in the eligibility list.

Were certain types of colleges, universities, and community organizations specifically highlighted as eligible?

Yes. The FOA highlighted inclusion of organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions (AANAPISIs). It also referenced faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Are foreign institutions eligible to apply?

No. Foreign institutions were not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations were not eligible.

Are foreign components allowed at all under this opportunity?

Yes. Foreign components, as defined under the NIH Grants Policy Statement, were allowed. This generally means a U.S. applicant organization could include certain international elements if they fit NIH policy and were well-justified scientifically.

When was this funding opportunity posted and created?

It was posted and created on April 26, 2013.

What was the application closing date?

The original and current application closing date was August 15, 2013.

Is this FOA still active?

No. The archive date was September 15, 2013, indicating the FOA is no longer active for new submissions under that solicitation.

Where did NIH direct applicants for official details and the full announcement?

NIH provided an additional information link to the full announcement on the NIH grants website.

Who should be contacted for access issues or technical problems related to the FOA link?

NIH included contact instructions through the NIH Office of Extramural Research (OER) web support for access or technical linking problems.

In practical terms, what was this FOA trying to build or support?

It aimed to build or support center-based programs capable of conducting coordinated, clinically focused medications development efforts for SUDs, potentially spanning candidate selection, translational justification, and clinical evaluation, with NIH involvement characteristic of the cooperative agreement model.

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