REDAC Full Committee Federal Register Notice April 2022

To view an accessible version of this information, please visit federalregister.gov.

The Summer Slice

Postmortem Blood Genomics Biorepository

FAA Office of Aerospace Medicine 
Civil Aerospace Medical Institute

Report No: DOT/FAA/AM-24/03

Title and Subtitle: Postmortem Blood Genomics Biorepository

Report Date: August 2024

Authors:

Hilary A. Uyhelji (https://orcid.org/0000-0002-3433-8320)
Christopher J. Tracy (https://orcid.org/0000-0002-4532-3327)
Vicky L. White (https://orcid.org/0009-0007-1164-5233)
Scott J. Nicholson (https://orcid.org/0000-0002-2201-744X)

Abstract: The Federal Aviation Administration Civil Aerospace Medical Institute Bioaeronautical Sciences Research Laboratory (BSRL) collects, processes, and analyzes forensic fluid and tissue samples from fatal civil aviation accidents in the United States. The BSRL issues standardized forensic sample collection kits(ToxBoxes) for medical examiners and coroners to collect and ship the samples needed for toxicological analysis. The BSRL Forensic Sciences section receives and assays incoming forensic samples to determine if the pilot consumed or was exposed to known drugs or toxic substances. This information is collected on behalf of the National Transportation Safety Board to assist in accident investigation. The BSRL Functional Genomics Research team previously examined gene expression patterns in such forensic samples. However, ToxBox forensic samples were not routinely preserved in a manner that prevented the degradation of those patterns during collection and storage. This report details establishment of protocols and selection of tubes to supplement ToxBox collections with preservation of blood for functional genomics analyses. To preserve ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) in forensic samples and establish a biorepository of samples suitable for future gene expression analyses, a supplemental whole blood research specimen collection kit is now included in ToxBoxes. These kits have been distributed in ToxBoxes since August 2022.

Key Words: Biorepository, aviation accident investigation, RNA, DNA

No. of Pages: 19

Biomarkers for Noise-Induced Sleep Disruption

FAA Office of Aerospace Medicine 
Civil Aerospace Medical Institute

Report No: DOT/FAA/AM-25/09

Title and Subtitle: Biomarkers for Noise-Induced Sleep Disruption

Report Date: April 2025

Authors:
Hilary A. Uyhelji (https://orcid.org/0000-0002-3433-8320)
Mathias Basner (https://orcid.org/0000-0002-8453-0812)
Christopher W. Jones (https://orcid.org/0000-0002-8173-721X)

Abstract:

Noise experienced by the general population in proximity to airports and aviation flight routes can result in disrupted sleep. Sleep disruption and fragmentation may be mitigated by wearing earplugs or introducing broadband noise (e.g., pink noise) into the bedroom. However, these countermeasures are poorly investigated and understood. The FAA ASCENT has supported the University of Pennsylvania in investigating earplugs and pink noise to mitigate sleep disruption from simulated aircraft noise, using approaches such as physiological and neurobehavioral performance monitoring. The FAA Civil Aerospace Medical Institute complemented these efforts by receipt of blood samples collected from human subjects exposed to the simulated aircraft noise and monitored by the University of Pennsylvania. Ribonucleic acid (RNA) was extracted from the blood followed by total RNA sequencing and differential gene expression analyses, which provided molecular insights about human responses to noise and the mitigations tested. Altogether 1,246 genes were differentially expressed in response to the experimental exposure condition (control without noise, pink noise at a level of 50 dBA, simulated aircraft noise, and simulated aircraft noise with a mitigation: pink noise at 40 dBA, pink noise at 50 dBA, or earplugs). There were 2,181 genes associated with awakenings during noise exposure.

Key Words: Aviation noise; Pink noise; Sleep loss; Fatigue

No. of Pages: 10

Exploratory Development of Biomarkers for Neurobehavioral Performance Impairment During Sleep Loss: Comparison Across Multiple Types of Sleep Deprivation

FAA Office of Aerospace Medicine 
Civil Aerospace Medical Institute

Report No: DOT/FAA/AM-25/08

Title and Subtitle: Exploratory Development of Biomarkers for Neurobehavioral Performance Impairment During Sleep Loss: Comparison Across Multiple Types of Sleep Deprivation

Report Date: June 2025

Authors: Hilary A. Uyhelji, Scott J. Nicholson, Thomas E. Nesthus, Julia L. Beckel, Elizabeth B. Klerman, Charles A. Czeisler, Robin K. Yuan, Arturo Arrona-Palacios, Pamela Song, Joseph M. Ronda, Jason P. Sullivan, Michael S. Goodson

Abstract:

Inter-individual variation in response to insufficient or altered timing of sleep presents a challenge for the development of personalized approaches to fatigue monitoring and mitigation. Besides health impacts, insufficient sleep can result in impaired neurobehavioral performance and pose a substantial risk of injury and even mortality in safety-critical operations such as transportation. The present study provides a detailed exploration of physiological, neurobehavioral, and gene expression changes during sleep restriction, acute total sleep deprivation, and altered timing of sleep among 59 healthy volunteer participants who completed a 10-day inpatient study.

Reducing the quantity or altering the timing of sleep significantly impacts self-reported estimates of sleep duration, polysomnography-recorded sleep stages, and neurobehavioral performance test results. Impaired neurobehavioral performance was associated with transcriptomic changes in gene expression. A comparison of current and prior research on total sleep deprivation indicated that reproducible candidate gene expression biomarkers exist for at least one metric of attention, specifically, Psychomotor Vigilance Test (PVT) lapses.

Candidate biomarkers of fatigue-related impairment were identified that responded to single neurobehavioral performance endpoints, as well as those that responded to multiple types or metrics of performance. Reproducible identification of biomarker candidates for PVT lapses during total sleep deprivation increases confidence in the ability to June 2025 iv Comparison Across Multiple Types of Sleep Deprivation develop a molecular approach to fatigue-related impairment detection, while novel discoveries expanded the list of candidate genes to other impairment metrics. Molecular biomarkers for neurobehavioral performance impairment represent a potentially valuable tool to more precisely monitor the neurobehavioral performance deficits resulting from sleep loss, and further research and validation could one day augment fatigue risk management practices that historically emphasize scheduling and rest opportunities. The data generated from self-assessment, polysomnography, neurobehavioral performance, and molecular investigations provide a wealth of information made publicly available for further data mining and scientific advancements.

Key Words: Total sleep deprivation; Sleep restriction; Shiftwork; Neurobehavioral performance impairment; Fatigue; Psychomotor; vigilance test; Gene expression biomarkers

No. of Pages: 28

Guidance for Foreign State Instrument Flight Procedure and Airport Review

The FAA issued a Notice in 2025 to discontinue its review and approval process for foreign Required Navigation Performance (RNP) Authorization Required (AR) procedures (OpSpec C384) and foreign CAT II/III airport facilities (OpSpec C060). In addition, OpSpec C058, Special Restriction for Foreign Instrument Procedures, was decommissioned.

Foreign RNP AR procedure and foreign CAT II/III airport facilities design has matured to the point that FAA approval is no longer required.

Doing Business through eFAST

Profile of an eFAST MOA

Community Engagement – Jacksonville

The Federal Aviation Administration (FAA) is proposing to modify the airspace over Jacksonville International Airport in Florida. Under the proposed changes, existing flight paths would not change but where pilots are required to interact with Air Traffic Control would expand. The airspace change is to better manage the complexity and volume of aviation activities in the area. The purpose of the meeting is to ask for comments on the proposal’s effect on local aviation operations.

...

Community Engagement – Daytona

The Federal Aviation Administration (FAA) is proposing to modify the airspace over Daytona Beach International Airport in Florida. Under the proposed changes, existing flight paths would not change but where pilots are required to interact with Air Traffic Control would expand. The airspace change is to better manage the complexity and volume of aviation activities in the area. The purpose of the meeting is to ask for comments on the proposal’s effect on local aviation operations.

...

REDAC Full Committee Federal Register Notice October 2022

To view an accessible version of this information, please visit federalregister.gov.