Notice Number: NOT-EB-19-017

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 Research 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 radiation 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, small-scale biological monitoring devices and biosensors are sought to address the complex spectrum of needs associated with trauma care.

Research Objectives

This Notice invites research projects that seek to fill gaps in trauma care through the development of wearable or hand-held radiation monitors 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.

NIBIB Statement of Interest

The NIBIB is interested in projects focused on developing new devices and biomaterials that can facilitate evaluation (and potential treatment) of radiation exposures in the dynamic trauma environment. The central focus is not to measure radiation levels (contamination) on the victim's skin/clothing or environment, but to aid in assessing the extent of radiation tissue / organ dose (absorbed radiation) received during a radiation exposure incident. Topics identified as high interest include, but are not limited to, the following:

• Wearable or hand-held monitors for measuring skin and tissue radiation exposure (reported in Sieverts) including possible estimates of radiation type (gamma, beta, alpha exposures)
• Biosensing patches or gels that can give an indication or readout of the severity of skin radiation exposure, which could help to indicate any immediate therapies for minimizing tissue damage or promoting healing
• Portable devices for identifying specific isotopes and/or delivering half-life decay measurements of human radiation contamination, including methods to determine whether radioactive material has been ingested or inhaled
• 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 of victim exposure (and/or internalized radiation sources)

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 listed funding opportunity announcements must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-EB-19-017” (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 withdrawn from consideration for this initiative.

Inquiries