Notice of Change to RFA-DA-23-053, "HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)"
Notice Number:
NOT-DA-23-054

Key Dates

Release Date:

February 8, 2024

Related Announcements

  • August 3, 2022 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional).  See NOFO RFA-DA-23-053

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to inform potential applicants of changes to the notice of funding opportunity (NOFO) HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional), RFA-DA-23-053.

Part 1. Overview Information

Key Dates

Currently reads:

Application Due DatesReview and Award Cycles
NewRenewal / Resubmission / Revision (as allowed)AIDSScientific Merit ReviewAdvisory Council ReviewEarliest Start Date
March 20, 2024March 20, 2024Not ApplicableJuly 2024October 2024December 2024

Expiration Date     March 21, 2024

Modified to read (in Bold Italic):

Application Due DatesReview and Award Cycles
NewRenewal / Resubmission / Revision (as allowed)AIDSScientific Merit ReviewAdvisory Council ReviewEarliest Start Date
March 20, 2024March 20, 2024Not ApplicableJuly 2024October 2024December 2024
October 17, 2024October 17, 2024Not ApplicableFebruary 2025May 2025July 2025
March 20, 2025March 20, 2025Not ApplicableJuly 2025October 2025December 2025

Expiration Date   March 21, 2025

 

 

 

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Special Considerations

Currently reads:

The following applications will be considered non-responsive and will not be reviewed:

  • Applications testing new clinical interventions to prevent or treat opioid addiction (i.e., drugs, devices, behavioral therapies). (Note applications may test adaptations of existing interventions, health services interventions, new recovery support interventions, etc.)
  • Applications that do not address effectiveness, services, or implementation questions relevant to one or more of the following pillars of the HHS Overdose Prevention strategy: harm reduction, treatment of opioid use or stimulant use disorder, and recovery support.
  • Applications that do not include a timeline and milestones plan. (see instructions in Section IV. SF424 (R&R) Other Project Information)

Modified to read (in Bold Italic):

The following applications will be considered non-responsive and will not be reviewed:

  • Applications testing new clinical interventions to prevent or treat opioid addiction (i.e., drugs, devices, behavioral therapies). (Note applications may test adaptations of existing interventions, health services interventions, new recovery support interventions, etc.)
  • Applications that do not address effectiveness, services, or implementation questions relevant to one or more of the following pillars of the HHS Overdose Prevention strategy: harm reduction, treatment of opioid use or stimulant use disorder, and recovery support.
  • Applications that do not include a timeline and milestones plan and a stakeholder engagement plan. (see instructions in Section IV. SF424 (R&R) Other Project Information)

 

 

Section IV. Application and Submission Information- 

Section IV.2. Content and Form of Application Submission

SF424(R&R) Other Project Information

Currently reads:

All instructions in the SF424 (R&R) Application Guide must be followed.

Timeline & Milestone Plan (Required - 2 page maximum)

Applicants should include a Timeline and Milestone Plan, clearly specifying proposed milestones and when those milestones are expected to be achieved. Milestones for both phases should be specified, though it is expected that R33 milestones may change based on results from the R61 phase for awards that transition to the R33 phase.

Stakeholder Engagement Plan (Required 2 page maximum)

Applications are encouraged to include detailed plans for engaging key stakeholders, including patients, families, providers, payers, and community leaders, as appropriate to the specific goals of their study.

Modified to read (in Bold Italic):

All instructions in the SF424 (R&R) Application Guide must be followed.

Timeline & Milestone Plan (Required - 2 page maximum)

Applicants must include a Timeline and Milestone Plan, clearly specifying proposed milestones and when those milestones are expected to be achieved. Milestones for both phases should be specified, though it is expected that R33 milestones may change based on results from the R61 phase for awards that transition to the R33 phase

Stakeholder Engagement Plan (Required 2 page maximum)

Applications must include detailed plans for engaging key stakeholders, including patients, families, providers, payers, and community leaders, as appropriate to the specific goals of their study.

All other aspects of this NOFO remain the same.

Inquiries

Please direct all inquiries to:

Carrie Mulford, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301827-6473
Email: carrie.mulford@nih.gov