Notice Number: NOT-TR-19-007
Key Dates
Release Date: October 15, 2018Estimated Publication Date of Funding Opportunity Announcement: December 01, 2018
First Estimated Application Due Date: February 28, 2019
Earliest Estimated Award Date: September 30, 2019
Earliest Estimated Start Date: September 30, 2019
Related Announcements
None
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
The National Center for Advancing Translational Sciences (NCATS), as part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative, intend to publish a Funding Opportunity Announcement (FOA) to create and test devices that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction, or opioid use disorders (OUDs), using human tissues in in vitro microphysiological systems (MPS), also known as tissue chips or organs-on-chip . The FOA will invite applications for development and validation of highly reproducible and translatable in vitro MPS models that can be utilized for preclinical efficacy studies by providing information on the discovery and validation of translatable biomarkers, development of standardized methods for preclinical efficacy testing, and definitive efficacy testing of candidate therapeutics using best practices and rigorous study design.
An essential feature of funded projects will be a multidisciplinary approach that brings together experts in pain and opioid use disorders (OUD), bioengineering, microfluidics, material science, "omic" sciences, computational biology, disease biology, pathology, electrophysiology, pharmacology, biostatistics and clinical science. Partnerships between MPS developers and relevant pain/OUD disorder (which includes addiction, tolerance, withdrawal and overdose) experts, plus clinical researchers and/or patient cohorts (if applicable) will be essential.
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 December 2018, with an expected application due date in February 2019. This FOA will utilize the UG3/UH3 activity code, which supports a bi-phasic Cooperative Agreement to support innovative exploratory and development research activities with substantial involvement from NIH program staff. Details of the planned FOA are provided below.
Research Initiative Details
The goals of this initiative are to develop and demonstrate the utility of microphysiological systems (MPS) to model pain-relevant and opioid use disorder (OUD) mechanisms in in vitro systems using human tissues to more accurately recapitulate human phenotypes; and to identify and test novel therapeutics or treatments in these systems that will be informative for preclinical efficacy and safety studies.
The initial UG3 phase will support studies to develop and demonstrate functional validation of tissue chip platforms that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction, or opioid use disorders (OUDs), and/or their respective therapies and treatments, using physiologically-relevant human cells and tissues in in vitro microphysiological systems (MPS). The UH3 phase will support studies to demonstrate the functional utility of the nociception/addiction/OUD tissue chip models for identification of novel therapeutics or treatment mechanisms by identifying aspects of pain circuitry, disease biology or offering new avenues for drug screening and assessment of novel candidate analgesics and therapies against OUD and overdose.
Applicants are expected to document the formation of partnerships and collaborations with appropriate partners including but not limited to researchers in the pain/addiction/overdose field, clinicians working in the OUD and medication assisted therapy (MAT) field, and patient cohorts for both pain and opioid-related disorders.
As part of the HEAL Initiative, this FOA is subject to certain requirements for for-profit applicant organizations. Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.
Applicants are strongly encouraged to leverage existing research resources for their studies whenever possible.
Funding Information
Estimated Total Funding $5M/year dependent on appropriations.
Expected Number of Awards 4-6
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.350
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)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Inquiries
Please direct all inquiries to:
Email:lucie.low@nih.gov
Danilo Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: Danilo.Tagle@nih.gov
Margaret Sutherland, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: sutherlandm@ninds.nih.gov
and Human Services (HHS)
