Key Dates

Related Announcements

PAR-20-316 - NIH Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 - Clinical Trial Optional)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute of Allergy and Infectious Diseases (NIAID)

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

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

Purpose

The purpose of this notice is to add responsiveness criteria and to provide further clarification of the clinical trials permitted in Funding Opportunity Announcement (FOA), PAR-20-316 "Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional)". This notice is intended to provide more guidance in developing grant applications that are more responsive to the scientific scope of the FOA. Changes to the FOA are shown below.

The following section of PAR-20-316 has been modified:

Currently Reads:

Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description:

D. Scientific Scope

This FOA primarily supports translational research. Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The categories of research supported under this program include but are not limited to:    

CounterACT RCE should strive to develop a comprehensive drug discovery and development program that includes all the above components (target identification, lead identification, and lead optimization). The development of a pipeline of candidate therapeutics should be designed to support several projects for which the applicant(s) can demonstrate a high level of synergy that increases the probability of achieving the goal of at least one successful lead or optimized lead compound by the end of the project period.

Only mechanistic studies that meet the NIH clinical trial definition will be supported; mechanistic trials are studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.  Good Laboratory Practices (GLP) IND-enabling safety studies and pivotal efficacy studies in animals, cGMP production, and other studies required for most clinical trials will not be supported in this FOA.  However, in some rare cases when sufficient preclinical studies have been completed, the opportunity for a small mechanistic clinical trial may arise and may be included if this research facilitates the overall goals within the above stated scientific scope of the FOA (i.e. basic research through lead optimization).   Phase 1 and higher trials are not supported through this program.

• Mechanistic research to identify targets for therapeutic development;
• Demonstration of in vitro activity of candidate(s), and generation of preliminary in vivo proof-of-concept efficacy data;
• Identification of lead candidate therapeutics using primary and secondary screening efforts, and other methods as described in PAR-19-039 Identification of Therapeutic Lead Compounds (U01);
• Optimization of lead candidate therapeutics using human-relevant animal models, bioanalytical assay development, laboratory-scale and scale-up manufacturing, and other methods described in PAR-19-040 Optimization of Therapeutic Lead Compounds (U01).

N. Applications Not Responsive to this FOA

• Applications that propose research on chemical threats that are not listed in Section I.B. Chemical Threats of Research Interest (above in this FOA) will be considered non-responsive and will not be reviewed for this FOA.

Modified to Read (additional language shown in italics):

Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description:

D. Scientific Scope

This FOA primarily supports translational research. Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The categories of research supported under this program include but are not limited to:

CounterACT RCE should strive to develop a comprehensive drug discovery and development program that includes all the above components (target identification, lead identification, and lead optimization).The development of a pipeline of candidate therapeutics should be designed to support several projects for which the applicant(s) can demonstrate a high level of synergy that increases the probability of achieving the goal of at least one successful lead or optimized lead compound by the end of the project period.

Clinical Trial Information

Only mechanistic studies that meet the NIH clinical trial definition will be supported; mechanistic trials are studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. In some rare cases when sufficient preclinical studies have been completed, the opportunity for a small mechanistic clinical trial may arise and may be included if this research facilitates the overall goals within the above stated scientific scope of the FOA (i.e. basic research through lead optimization). Phase 1 and higher trials are not supported through this program.

• Mechanistic research to identify targets for therapeutic development;
• Demonstration ofinvitroactivity of candidate(s), and generation of preliminary in vivo proof-of-concept efficacy data;
• Identification of lead candidate therapeutics using primary and secondary screening efforts, and other methods as described in PAR-19-039 Identification of Therapeutic Lead Compounds (U01);
• Optimization of lead candidate therapeutics using human-relevant animal models, bioanalytical assay development, laboratory-scale and scale-up manufacturing, and other methods described in PAR-19-040 Optimization of Therapeutic Lead Compounds (U01).

For applications proposing a clinical trial, note the following definitions and restrictions for this funding announcement:

• Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following type of clinical trial is responsive:
  • Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).

Applicants are strongly encouraged to speak with the assigned Scientific/Research Contact prior to application.

• For further clarification on how NIH defines the different types of clinical trials, please refer to the following resources:
  • NOT-OD-15-015: Notice of Revised NIH Definition of “Clinical Trial”
  • NIH's Definition of a Clinical Trial
  • Decision Tree for NIH Clinical Trial Definition
  • NIH Definition of Clinical Trial Case Studies

N. Applications Not Responsive to this FOA

• Applications that propose research on chemical threats that are not listed in Section I.B. Chemical Threats of Research Interest (above in this FOA) will be considered non-responsive and will not be reviewed for this FOA.
• Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions.
• Good Laboratory Practices (GLP) IND-enabling safety studies and pivotal efficacy studies in animals, cGMP production, and other studies required for most clinical trials will not be supported in this FOA.
• Delayed onset studies. A Delayed Onset Study is where research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application (see https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy).

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

David A. Jett, Ph.D.
National Institute of Neurological Disorder and Stroke (NINDS)
Telephone: 301-768-9584
Email: jettd@ninds.nih.gov