Notice Number: NOT-EB-19-018

Key Dates
Release Date: August 29, 2019
First Available Due Date: October 5, 2019
Expiration Date: January 8, 2022

PA-18-418 "NIBIB Research Project Grant (R01 Clinical Trial Required)"
PA-19-056 "NIH Project Grant (Parent R01 Clinical Trial Not Allowed)"

Issued by
National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The purpose of this Notice is to inform potential applicants to the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of an area of special interest in developing physiological sensors for application in trauma care.

Background

Trauma care focuses on the critical time immediately after an injury or acute shock, in an event that may affect one person or many. Termed the golden hour, the exact window of time depends on many variables, including the patient’s underlying health, the nature of the traumatic occurrence, the scale of casualties, and the equipment and expertise at hand. The trauma environment is constantly changing due to ongoing injury, the possible involvement of multiple tissue types, modulation by the immune system, and/or infection. To broadly address trauma care the National Institute of Biomedical Imaging and Bioengineering (NIBIB), Uniformed Services University of the Health Sciences (USUHS), and Food and Drug Administration (FDA) cosponsored a workshop on March 21 22, 2019 to link the needs of the Department of Health and Human Services and the Department of Defense with nascent bioimaging and bioengineering solutions. Among the biotechnological gaps identified at the meeting, biological monitoring devices that can be deployed outside of the hospital setting, including use of devices well beyond a literal hour of time before reaching a hospital, are sought to address the complex spectrum of needs. Additionally, a high priority across technologies and settings are novel approaches to effectively collecting, accessing, and using data associated with trauma care.

Research Objectives

This Notice invites research projects that seek to fill gaps in trauma care such as rapid triage and accurate risk assessment through the development of physiological monitors, biochemical agent detectors, and point of care technologies capable of operating in dynamic environments. Applications should involve expertise across multiple disciplines as relevant to the proposed research. Applications can address different technology development stages, from early technology development to testing in animal models and human subject research. Projects focused on the development of sensing modalities should prioritize wearable and minimally invasive sensors (e.g. microneedle patches). Projects proposing to integrate sensors into armbands / wrist watches or enable the sensor readout through a smartphone application are not appropriate for this Notice.

NIBIB Statement of Interest

The NIBIB is interested in projects focused on developing new acquisition and interpretation hardware and software for non-invasive and minimally invasive physiological monitors (e.g. microneedle patches), diagnostic, and therapeutic techniques to be used in the dynamic trauma environment. Topics identified as high interest include, but are not limited to, the following:

• Advance algorithm and deep learning techniques for continuous analysis and interpretation of multiple physiological data streams from multiplexed sensors
• Sensors for noninvasive or minimally invasive measurement of relevant biochemical markers and vital signs (e.g. O2 saturation), pathogens, biochemical agents, or hormones in biofluids (e.g. sweat, saliva, interstitial fluid)
• Rapid toxicology screening systems
• Small, portable, rugged devices capable of autonomous operation, utilizing flexible materials for improved wearability and ease of operation, and offering optical or sound-based readout options
• Closed loop electrocardiogram systems with digital health readouts
• Portable technologies utilizing sensor arrays for pulmonary disease diagnostics
• Technologies for wound diagnostics

Application and Submission Information:

This Notice applies to due dates on or after October 5, 2019 and subsequent receipt dates through January 8, 2022.

Applications for this Notice must submit an application through NIH Parent Announcement PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) or, if you are proposing a clinical trial, to PA-18-418: NIBIB Research Project Grant (Parent R01 Clinical Trial Required). Note that applications to PA-18-418 should propose early-stage clinical trials through Phase I, first-in-human, safety, feasibility or other small clinical trials that inform early-stage technology development. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials or trials in which the primary outcome is efficacy, effectiveness or a post-market concern.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-EB-19-018 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Inquiries