Key Dates

NOT-NS-21-034 - Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics]

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

The National Institute for Neurological Disorders and Stroke, along with other NIH Institutes and Centers (ICs), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for team-based research projects that develop assays, screens and propose early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and/or validation of pharmacodynamic markers and efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies will also be responsive to this FOA.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in March, 2021 with an expected application due date in April, 2021.

This FOA will utilize the U19 activity code. Details of the planned FOA are provided below.

Through targeted research efforts, the NIH HEAL Initiative proposes to accelerate the discovery and preclinical development of new medications to treat pain. This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe and effective therapeutics to treat pain with little or no addiction liability.

The following is a list of these coordinated funding announcements:

RFA-NS-21-016: HEAL Initiative: Planning Studies for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)

RFA-NS-21-016 will support planning projects that are designed to support building a strong research team, develop feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent U19 application, RFA-NS-21-015.

RFA-NS-21-015 HEAL Initiative: Team Research - for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed)

RFA-NS-21-015 will support team-based research projects that develop assays, screens and propose early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and/or validation of pharmacodynamic markers and efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies are responsive to RFA-NS-21-015.

RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

Applications to RFA-NS-21-010 require a promising small molecule or biologic hit or lead for optimization, a rigorous biological rationale for the intended approach, and scientifically sound assays for testing the optimization of the hit or lead. In addition, a strong package of data linking the putative therapeutic target to the proposed disease indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the pain type is required.

The goal of this FOA, RFA-NS-21-015, is to support interdisciplinary and even multi-institutional research teams working on early therapeutics development to advance a hit or lead asset to the point where it can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the 5 years of the award. There is no opportunity for renewal of this award.

Webinar

In order to learn more about this FOA and to have the opportunity to ask questions, a pre-application informational webinar will be held on Thursday, March 11, 2021 from 3:00-4:00 pm EDT (12:00-1:00pm PDT).This webinar will also be recorded and disseminated to the general public. Information on how to join the webinar is provided below:

RFA Webinar: "HEAL Initiative: Translational Efforts in Non-addictive Analgesic Development"

To join the web presentation, at least 10 minutes before the starting time:

1. Go to https://nih.zoomgov.com/j/1601307575?pwd=R2ZjK2lKNUJJVlQ4ek1BamtrRE5ZUT09

2. Click "Join Now"

For audio you can follow the prompts on your monitor, or:

Call-in toll number (US):

+1 669 254 5252 US (San Jose)
+1 646 828 7666 US (New York)
+1 669 216 1590 US (San Jose)
+1 551 285 1373 US

Find your local number: https://nih.zoomgov.com/u/adqgk3nzZN

Meeting ID: 160 130 7575
Passcode: 574104

For assistance please contact Alex Tuttle, Ph.D. [E] alex.tuttle@nih.gov

Applications are not being solicited at this time.

Please direct all inquiries to:

Michael Oshinsky

National Institute of Neurological Disorders and Stroke (NINDS)

301-496-9964

michael.oshinsky@nih.gov

D.P. Mohapatra, PhD

National Institute of Neurological Disorders and Stroke (NINDS)

Telephone: 301-496-9964

Email: dp.mohapatra@nih.gov

Rebecca Roof, PhD

National Institute of Neurological Disorders and Stroke (NINDS)

Telephone: 301-496-1779

Email: Rebecca.Roof@nih.gov