HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
Activity Code
UG3/UH3Â Exploratory/Developmental Phased Award Cooperative Agreement
Funding Opportunity Announcement (FOA) Number
RFA-NS-21-010
Funding Opportunity Purpose
The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads to Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase II clinical studies. Applicants must have a promising biologic or small molecule hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, development of a pharmacodynamic/target engagement biomarker, assembly and filing of an Investigational New Drug (IND) application and Phase I clinical testing. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.
Key Dates
Application Due Date(s)
November 18, 2020, March 24, 2021, July 14, 2021, October 15, 2021, February 15, 2022, June 15, 2022, by 5:00PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
AIDS Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
Scientific Merit Review
February 2021, June 2021, October 2021, February 2022, June 2022, October 2022
Advisory Council Review
May 2021, October 2021, January 2022, May 2022, October 2022, January 2023
Earliest Start Date
June 2021, November 2021, February 2022, April 2022, November 2022, February 2023
Expiration Date
September 08, 2022