Notice of Change for RFA-DA-25-056, Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed)

NOT-DA-25-034

Key Dates

Related Announcements

• May 30, 2024 - Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed). See NOFO RFA-DA-25-056. 

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to inform potential applicants of four (4) changes for RFA-DA-25-056 , “Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed)”.

First Change:

The Funding Opportunity Title has been revised.

Currently reads:

Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed).

Modified to Read: (changes in bold Italic):

Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trials Not Allowed).

Second Change:

The application due date and NOFO expiration date have been extended to December 6 and 7, 2024, respectively.

In Part 1. Overview Information, Key Dates, the following section has been changed:

Currently reads:

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS - New/Renewal/Resubmission/Revision, as allowed	Scientific Merit Review	Advisory Council Review	Earliest Start Date
November 13, 2024	Not Applicable	Not Applicable	March 2025	May 2025	July 2025

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date

November 14, 2024

Modified to Read: (changes in bold Italic)

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS - New/Renewal/Resubmission/Revision, as allowed	Scientific Merit Review	Advisory Council Review	Earliest Start Date
December 6, 2024	Not Applicable	Not Applicable	March 2025	May 2025	July 2025

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date

December 7, 2024

Third change:

In Section IV. Application and Submission Information, Content and Form of Application Submission, the following has been changed:

Currently reads:

Component	Component Type for Submission	Page Limit	Required/Optional	Minimum	Maximum
Overall	Overall	12	Required	1	1
Outreach and Networking	Project	6	Required	1	1
Drug Development Training and Education	Project	6	Required	1	1
Subproject Management	Project	6	Required	1	1

Modified to Read: (changes in bold Italic)

Component	Component Type for Submission	Research Strategy/ Program Plan Page Limit	Required/ Optional	Minimum	Maximum
Overall	Overall	12	Required	1	1
Administrative Core	Admin Core	6	Required	1	1
Outreach and Networking	Core	6	Required	1	1
Drug Development Training and Education	Core	6	Required	1	1
Subproject Management	Project	12	Required	1	No Maximum

In Section IV. Application and Submission Information, Budget (Overall), the following section has been changed:

Currently reads:

The total direct cost for the Center should not exceed $1.9 million per year. The direct cost for individual subawards should not exceed $200,000 and varies depending on the specific experiments.

Component Type for Submission	Budget
Overall (Administrative)	$100,000
Outreach and Networking	$100,000
Drug Development Training and Education	$300,000
Subproject Management	$1,400,000

Modified to Read: (changes in bold Italic)

The total direct cost for the Center should not exceed $1.9 million per year. The direct cost for individual subawards should not exceed $200,000 and varies depending on the specific experiments. Suggested Budget Caps (Direct costs only) listed below:

Component Type for Submission	Budget
Administrative Core	$100,000
Outreach and Networking	$100,000
Drug Development Training and Education	$300,000
Subproject Management	$1,400,000

Fourth change:

In PHS 398 Research Plan (Administrative Core), the following are instructions for the Admin Core. 

Specific Aims: State the specific aims for the Administrative Core and provide a rationale and description of how each aim enhances the operation of the Center. In addition, state the core’s relationship to the proposed Center’s goals and how it is related to the other Components of the Center in the application.

Research Strategy: Applicants must explain the plans for organizational and administrative management for the Center overall, for coordination and communication within the Center, and for coordination and communication with NIDA. Applicants must explain the project management oversight process and describe a plan for tracking progress for all aspects of the component projects and include a description of any platforms or software used to track Center progress. Plans for ensuring compliance with all applicable NIH guidelines and policies and monitoring the progress of the experiments, management of day-to-day program activities, management of contractual agreements (if applicable), submission of all required technical reports, and maintenance of fiscal and programmatic systems to ensure accountability and performance tracking must be described. Applicants should describe how the Administrative Core Lead’s administrative, management, and leadership capabilities adequately provide for all activities listed above.

All other aspects of this NOFO remain the same.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact:

Tam Nguyen, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-451-1203
Email: tam.nguyen@nih.gov