Federal Register #FAA20250583

FAA Airworthiness Directive for Boeing 747-400 Freighters and FDA Device Classification

This summary covers recent regulatory actions and directives issued by the Federal Aviation Administration (FAA) and the Food and Drug Administration (FDA):

• Government Buyers

  • Federal Aviation Administration (FAA), Aircraft Certification Service
  • Food and Drug Administration (FDA)

• OEMs and Vendors Mentioned

  • Boeing (Boeing 747-400 series airplanes)
  • Israel Aerospace Industries Ltd. (Service Bulletin provider for inspections and repairs)

• Products and Services Requested

  • Inspection and repair services for crew oxygen bottle flexible hoses and adjacent wiring on Boeing 747-400 freighter aircraft
  • Applies to aircraft converted under STCs ST01676SE or ST01706SE
  • Service Bulletin: Israel Aerospace Industries Ltd. 36635157
  • Setmelanotide Eligibility Gene Variant Detection System
  • Classified as a Class II medical device for clinical chemistry and toxicology applications

• Unique or Notable Requirements

  • Inspections must address chafing, arcing damage, and clearance issues to prevent fire and oxygen loss
  • Repairs must follow the specific Israel Aerospace Industries Ltd. Service Bulletin
  • The airworthiness directive is mandatory for affected Boeing 747-400 freighter aircraft
  • The gene variant detection system is subject to FDA Class II controls for safety and effectiveness

• Places of Performance and Delivery

  • Gallatin County Airport, Sparta, KY (FAA airspace action)
  • 1600 Stewart Avenue, Suite 410, Westbury, NY (FAA office)
  • 2200 South 216th St., Des Moines, WA (FAA office)
  • Ben Gurion International Airport, Israel (related to Service Bulletin origin)

Description

This final rule establishes Class E airspace at Sparta, KY to support new instrument procedures and instrument flight rule (IFR) operations. The airspace extends upward from 700 feet above the surface to within a 6.5-mile radius of Gallatin County Airport. The rule is effective July 9, 2026, and is a routine and frequent airspace action by the Federal Aviation Administration under the Department of Transportation. No comments were received during the proposal phase, and the rule is not considered significant or economically impactful.

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