NOT-RM-22-014: Notice of Change in Funding Opportunity RFA-RM-22-015, IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)

Notice of Change in Funding Opportunity RFA-RM-22-015, IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)

Notice Number:

NOT-RM-22-014

Key Dates

Release Date:

June 8, 2022

Related Announcements

RFA-RM-22-015 - IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)

Issued by

Office of Strategic Coordination (Common Fund)

Purpose

The purpose of this Notice is to inform potential applicants of a change in the Funding Opportunity Description of RFA-RM-22-015, IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed). Previously this funding announcement did not allow the inclusion of animal model development in the research plans of applications. The purpose of this notice is to inform potential applicants that animal model development will now be allowed in applications to RFA-RM-22-015.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Currently Reads:

Research Scope

Applications Not Responsive to this FOA

The following applications will be considered non-responsive to this FOA and withdrawn from consideration without review:

Basic research of disease mechanisms
Development of animal models
Early activities such as target identification
Development of risk, detection, diagnostic, prognostic, efficacy prediction biomarkers
Applications lacking milestones
Stand-alone studies to identify, validate, or qualify a target engagement marker and other bioanalytical assays
Preclinical research alone without a clear and direct pathway to IND-enabling studies
Only screening activities to identify new therapeutic leads
Nonclinical studies of disease mechanism or therapeutic mechanism of action studies
Nonclinical studies for ex vivo genome editing therapeutic development
Development of diagnostics or diagnostic devices
Research focused entirely on biomarkers and/or clinical endpoint development
Clinical research and clinical trials involving human subjects, except those in scope using human samples to e.g., validate target engagement assays

Revised to read:

The following applications will be considered non-responsive to this FOA and withdrawn from consideration without review:

Basic research of disease mechanisms
Early activities such as target identification
Development of risk, detection, diagnostic, prognostic, efficacy prediction biomarkers
Applications lacking milestones
Stand-alone studies to identify, validate, or qualify a target engagement marker and other bioanalytical assays
Preclinical research alone without a clear and direct pathway to IND-enabling studies
Only screening activities to identify new therapeutic leads
Nonclinical studies of disease mechanism or therapeutic mechanism of action studies
Nonclinical studies for ex vivo genome editing therapeutic development
Development of diagnostics or diagnostic devices
Research focused entirely on biomarkers and/or clinical endpoint development
Clinical research and clinical trials involving human subjects, except those in scope using human samples to e.g., validate target engagement assays

All other aspects of the Funding Opportunity Announcement remain unchanged.

Inquiries

Please direct all inquiries to:

Chris H. Boshoff Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0664
Email: [email protected]