NOT-NS-20-106: Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

Notice Number:

NOT-NS-20-106

Key Dates

Release Date:

September 08, 2020

Estimated Publication Date of Funding Opportunity Announcement:

September 12, 2020

First Estimated Application Due Date:

November 16, 2020

Earliest Estimated Award Date:

June 01, 2021

Earliest Estimated Start Date:

June 30, 2021

Related Announcements

NOT-NS-19-040 - Notice to Extend the Expiration Date for RFA-NS-19-010 "Optimization of Non-addictive Therapies (Small Molecules and Biologics) to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)"

NOT-NS-19-026 - Notice of Change to Key Dates and Change to Matching Requirement Instructions for RFA-NS-19-010 "Optimization of Non-Addictive Therapies (Small Molecules and Biologics) to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)"

Reissuance of RFA-NS-19-010 - Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to inform potential applicants that the National Institute of Neurological Disorders and Stroke (NINDS), intends to publish a re-issuance of funding opportunity announcement RFA-NS-19-010 as well as to announce a pre-application webinar on September 15, 2020 from 3:00-4:00 pm EDT (12:00 -1:00pm PDT).

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 September 2020 with an expected application due date in November 2020.

This FOA will utilize the UG3/UH3 Clinical Trial Optional activity code. Details of the planned FOA and pre-application webinar are provided below.

Research Initiative Details

The goal of the intended FOA is to support preclinical optimization and development of safe, effective, and non-addictive analgesic 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 towards Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) https://heal.nih.gov/research/clinical-research/eppic-net or other Phase II clinical studies. Applicants must have a promising small molecule or biologic 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, pharmacodynamic or target engagement biomarker development, assembly of an Investigational New Drug (IND) application, and phase I clinical studies. 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.

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 September 15th from 3:00-4:00 pm EDT (12:00 -1:00pm PDT). Information on how to join the webinar is provided below:

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

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

1. Go to https://nih.webex.com/nih/onstage/g.php?MTID=e7de6b5b17d137af425ad083e5b7f9e69

2. Click "Join Now"

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

Call-in toll number (US/Canada): 1-650-479-3208
Access code: 126 784 1069

For assistance contact Tim Lyden at: timothy.lyden@nih.gov

Funding Information

Estimated Total Funding

Application budgets must reflect the actual needs of the proposed project but should not include the costs of NIH contract resources requested.

Expected Number of Awards

NIH intends to fund an estimated 5 awards for fiscal year 2021. Future awards will depend on annual appropriations.

Estimated Award Ceiling

Application budgets must reflect the actual needs of the proposed project but should not include the costs of NIH contract resources requested.

The total duration may not exceed 5 years.

Primary CFDA Numbers

93.853

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Regional Organization
Indian/Native American Tribal Government (Federally Recognized)
Independent school districts
U.S. Territory or Possession
Non-domestic (non-U.S.) Entity (Foreign Organization)
Public housing authorities/Indian housing authorities
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
County governments

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Charles Cywin, Ph.D.

National Institute of Neurological Disorders and Stroke (NINDS)

301-496-1779

Email: charles.cywin@nih.gov

Ann-Marie Broome, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: ann-marie.broome@nih.gov