Notice Number: NOT-AI-20-039

Key Dates
Release Date: March 17, 2020

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to provide clarification for potential applicants of an item cited under Additional Considerations described in RFA-AI-20-009, Three-Dimensional (3D) Human Biomimetics for Infectious Diseases (U19 Clinical Trial Not Allowed).

The following changes have been made to RFA-AI-20-009 under the heading specified.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Specific Areas of Research Interest

Additional Considerations

Current Text:

• Pathogens: Applicants are encouraged to develop tissue models that are relevant to one or more human pathogens.
• Cells: The use of organ explants or transformed / immortalized cell lines is discouraged, except for preliminary, proof of concept studies. The use of primary cells or pluripotent stem cells, e.g., induced pluripotent stem cells, is encouraged. Multipotent or unipotent stem cells also may be utilized where appropriate. The current NIH guidance on stem cell usage can be found at https://stemcells.nih.gov/policy/2009-guidelines.htm.
• Biomaterials: Native extracellular matrices (ECM) are dynamic, complex microenvironments that can drive functional and biomechanical development. Applicants should consider the biological properties and potential downstream effects when choosing ECM materials.
• Materials should be chosen to avoid confounding characteristics, e.g., the plastic polydimethylsiloxane (PDMS) binds hydrophobic drugs or reagents, which decreases the intended concentration, and can leach the endocrine disruptor cyclosilane into the medium.
• Collaborative Interactions: Model system(s) development will require extensive collaboration; thus, in depth communication between the infectious diseases and tissue engineering/tissue biology experts is imperative.
• Preliminary Data: Collaborative efforts between the Tissue Engineering and Infectious Diseases communities represent a recent scientific area for these communities; thus, substantial preliminary data will not be required but sufficient information should be supplied to establish the feasibility of the proposed research.

Revised to read:

• Pathogens: Applicants are encouraged to develop tissue models that are relevant to one or more human pathogens.
• Cells: The use of organ explants or transformed / immortalized cell lines is discouraged, except for preliminary, proof of concept studies. The use of primary cells or pluripotent stem cells, e.g., induced pluripotent stem cells, is encouraged. Multipotent or unipotent stem cells also may be utilized where appropriate. The current NIH guidance on stem cell usage can be found at https://stemcells.nih.gov/policy/2009-guidelines.htm.
• Biomaterials: Native extracellular matrices (ECM) are dynamic, complex microenvironments that can drive functional and biomechanical development. Applicants should consider the biological properties and potential downstream effects when choosing ECM materials.
• Materials should be chosen to avoid confounding characteristics. Please note that the use of polydimethylsiloxane materials does not represent an exclusion for grant applications responding to this RFA.
• Collaborative Interactions: Model system(s) development will require extensive collaboration; thus, in depth communication between the infectious diseases and tissue engineering/tissue biology experts is imperative.
• Preliminary Data: Collaborative efforts between the Tissue Engineering and Infectious Diseases communities represent a recent scientific area for these communities; thus, substantial preliminary data will not be required but sufficient information should be supplied to establish the feasibility of the proposed research.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Melody Mills, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3318
Email: millsm@niaid.nih.gov