Notice of NINDS Participation in PA-18-688 "Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R01 Clinical Trial Optional)

Notice Number: NOT-NS-18-049

Key Dates
Release Date: March 6, 2018

Related Announcements
PA-18-688

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) is participating in PA-18-688 "Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R01 - Clinical Trial Optional)".

The following sections have been updated to reflect the participation of NINDS in this FOA.

Currently Reads:
Part 1. Overview Information
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.865, 93.242

Part 2. Full Text Announcement

NIMH Area of Interest: The NIMH is specifically interested in clinical studies supporting the establishment of pharmacodynamic (PD) markers of psychopharmacologic drugs in pediatric populations.  For instance, a study using an EEG measure that would change in proportion to an administered drug dose (a CNS PD marker of drug action) would be of interest.  It is expected studies include dose ranging PK/PD measures.  Age-dependent effects would be of interest as well as the inclusion of comparator drugs. Using the EEG PD example, it is likely that the EEG measures reflecting drug action would be different in grade school children vs adults. 

Modified to Read:
Part 1. Overview Information
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.865, 93.242, 93.853

Part 2. Full Text Announcement

NIMH Area of Interest:The NIMH is specifically interested in clinical studies supporting the establishment of pharmacodynamic (PD) markers of psychopharmacologic drugs in pediatric populations.  For instance, a study using an EEG measure that would change in proportion to an administered drug dose (a CNS PD marker of drug action) would be of interest.  It is expected studies include dose ranging PK/PD measures.  Age-dependent effects would be of interest as well as the inclusion of comparator drugs. Using the EEG PD example, it is likely that the EEG measures reflecting drug action would be different in grade school children vs adults. 

NINDS Area of Interest: National Institute of Neurological Disorders and Stroke (NINDS) encourages applications on mission-relevant topics, particularly the study of pharmacodynamics of treatments for diseases affecting the nervous system. Examples include (but are not limited to) diseases and conditions in neonates (e.g., seizures, hypoxic-ischemic injury, stroke, neuromuscular disorders) and younger children (e.g., headache, epilepsy, movement disorders, neuromuscular disorders, stroke, demyelinating disorders) where age-related PD has not been explored and cannot be extrapolated from adult studies. Treatments for rare diseases affecting the CNS across the pediatric age spectrum are also of interest. Only treatments that have been approved by FDA for use in humans will be considered. Pharmacodynamic studies on experimental drugs may seek support via PAR-15-071. Applications may include clinical trials (as noted above); however, NINDS will not accept applications 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 (e.g., phase I, phase II, phase III clinical trials). Such designs should be submitted to a clinical trial-specific funding announcement (PAR-18-420 or PAR-18-422). Applicants are strongly advised to consult with NINDS Scientific/Research staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.

The following contacts have been added:
Section VII. Agency Contacts

Scientific/Research Contact(s)
Adam L. Hartman, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
E-mail: adam.hartman@nih.gov

Financial/Grants Management Contact(s)
Tijuanna Decoster, Ph.D. 
National Institute of Neurological Disorders and Stroke (NINDS) 
Telephone: 301-496-9231
E-mail:  tijuanna.decoster@nih.gov

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Adam L. Hartman, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
E-mail: adam.hartman@nih.gov