RFA-NS-21-010 - HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
National Institute of Neurological Disorders and Stroke (NINDS)
The purpose of this notice is to notify applicants of a clarification/change to the Award Project Period for and the PHS 398 Research Plan in RFA-NS-21-010 “HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional). The Award Project Period for the UG3 phase must be a minimum of 1 year and cannot exceed 2 years. Also, the instructions for the Discovery or Development stage has been moved to Research Strategy.
Currently reads:
Section II. Award Information
Award Project Period: The total duration may not exceed 5 years.
Modified to read:
Section II. Award Information
Award Project Period: The UG3 phase of the grant must be at least 1 year and cannot exceed 2 years. The UH3 phase must be at least 3 years and cannot exceed 4 years. The total duration may not exceed 5 years.
Currently reads:
Section IV. Application and Submission Information
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specify whether the application is proposed for entry at the Discovery or Development stage. Clearly indicate within a table which activities will be conducted by PD/PI and associated personnel (i.e. funded by the UG3/UH3 award) and which activities will be conducted by NIH contract research organizations and/or consultants. Include experimental designs and justification for all studies that will be conducted by the PD/PI and associated personnel. Activities that will be conducted by NIH contractors need not be described in detail in the application since these will be planned after the award by the LDT. An overview of the goals, rather than a detailed plan, should be provided in the application.
Specific Aims: The Specific Aims section should include Aims delineated for the UG3 and UH3 phases.
Research Strategy:
The Research Strategy section should include the following subsections:
Clinical Impact (Significance)
Biological Rationale (Significance)
Testing strategy (Approach)
Team management (Approach)
Innovation
Table of proposed activities that provides the following information: Activity (optimization effort, assays, PK, etc.), throughput (e.g. samples per month), source (PD/PI lab, sub awardee, NIH Contractor), advancement criteria.
Modified to read:
Section IV. Application and Submission Information
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: The Specific Aims section should include Aims delineated for the UG3 and UH3 phases. The UG3 phase of the grant must be at least 1 year and cannot exceed 2 years.
Research Strategy:
Specify whether the application is proposed for entry at the Discovery or Development stage. Clearly indicate within a table which activities will be conducted by PD/PI and associated personnel (i.e. funded by the UG3/UH3 award) and which activities will be conducted by NIH contract research organizations and/or consultants. Include experimental designs and justification for all studies that will be conducted by the PD/PI and associated personnel. Activities that will be conducted by NIH contractors need not be described in detail in the application since these will be planned after the award by the LDT. An overview of the goals, rather than a detailed plan, should be provided in the application.
The Research Strategy section should include the following subsections:
Clinical Impact (Significance)
Biological Rationale (Significance)
Testing strategy (Approach)
Team management (Approach)
Innovation
Table of proposed activities that provides the following information: Activity (optimization effort, assays, PK, etc.), throughput (e.g. samples per month), source (PD/PI lab, sub awardee, NIH Contractor), advancement criteria.
All other aspects of the FOA remain unchanged.
Mary Pelleymounter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-451-4551
Email: mary.pelleymounter@nih.gov
and Human Services (HHS)
