ForecastedResearch announcementOpportunity FOR-FD-25-009

Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed

Food and Drug Administration · Department of Health and Human Services

At a glance

Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed is a forecasted federal cooperative agreement opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Individual awards are listed as $2M, with about 5 awards expected. The notice is unrestricted by applicant type, subject to any clarifications in the notice. Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted: Aug 14, 2024
Est. close date: Not listed
Award floor: $2,000,000
Award ceiling: $2,000,000
Est. total funding: Not specified
Expected awards: 5
Cost sharing: Not required
Funding instrument: Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2025

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public colleges & universities
Federally recognized tribal governments
Public & Indian housing authorities
Native American tribal organizations
501(c)(3) nonprofits
Nonprofits without 501(c)(3) status
Private colleges & universities
For-profit organizations (not small businesses)
Small businesses
Unrestricted (any entity type)

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

To develop, disseminate, implement, and evaluate research needed in Anesthesia, Addiction Medicine and Pain Medicine in various fields of research. Specifically, research is needed in the following fields: function as a clinical trial endpoint and measurement of function in patients with chronic pain, outcome measures for clinical trials in stimulant use disorders, assessment of opioid clinical trials with active control in addition to placebo, neurodevelopmental outcome assessment of vulnerable pediatric patients exposed to anesthesia and opioid, and a living systematic review of pre-clinical studies of anesthetic neurotoxicity. Multiple awards may be considered. Applicants must propose a comprehensive evidence-based plan that advances appropriate prescribing of drug products intended for analgesia, anesthesia, and substance use disorders.

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above; no cost sharing is required.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Watch for the full noticeSave this grant to track when it opens.
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyTerrin Brown Grantor · terrin.brown@fda.hhs.gov Open ↗
Submit before the deadlineSubmit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

Reported obligations under ALN 93.103

Historical data · not a prediction

FY18

$173M

FY19

$199M

FY20

$212M

FY21

$219M

FY22

$256M est.

FY23

$247M est.

Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Who was funded under ALN 93.103

Historical data · not a prediction

Since October 1, 2023, 991 grant awards had funding actions under Food and Drug Administration Research, with 430 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

THE CRITICAL PATH INSTITUTE$56.2M
NATIONAL ENVIRONMENTAL HEALTH ASSOCIATION$39.7M
ASSOCIATION OF FOOD & DRUG OFFICIALS$29.5M
DUKE UNIVERSITY$19.1M
THE MEDICAL DEVICE INNOVATION CONSORTIUM$15.6M

Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

Terrin Brown Grantor
terrin.brown@fda.hhs.gov
2404027610

Quick answers

Is this opportunity open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for this opportunity?

The notice lists eligibility as unrestricted — open to any type of entity — subject to clarifications in the notice's additional eligibility information.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as $2m and the agency expects to make about 5 awards.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity FOR-FD-25-009), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

OpenResearchALN 93.103