[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75164-75167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30207]


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DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control


Update to the List of Medical Supplies

AGENCY: Office of Foreign Assets Control, Treasury.

ACTION: Notice, publication of updated list of items defined as medical 
supplies.

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SUMMARY: The Department of the Treasury's Office of Foreign Assets 
Control (OFAC) is publishing an updated list of items defined as 
medical supplies under section 560.530(a)(3)(ii) of the Iranian 
Transactions and Sanctions Regulations, 31 CFR part 560, and generally 
licensed for exportation or reexportation to Iran pursuant to section 
560.530(a)(3)(i), to include additional items.

DATES: Effective Date: November 2, 2015.

FOR FURTHER INFORMATION CONTACT: The Department of the Treasury's 
Office of Foreign Assets Control: Assistant Director for Licensing, 
tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 
202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, 
tel.: 202-622-2490; or the Department of the Treasury's Office of the 
Chief Counsel (Foreign Assets Control), Office of the General Counsel, 
tel.: 202-622-2410.

SUPPLEMENTARY INFORMATION:

Electronic and Facsimile Availability

    The text of the List of Medical Supplies and additional information 
concerning OFAC are available from OFAC's Web site (www.treasury.gov/ofac). Certain general information pertaining to OFAC's sanctions 
programs also is available via facsimile through a 24-hour fax-on-
demand service, tel.: 202-622-0077.

Background

    On October 22, 2012, OFAC published a final rule in the Federal 
Register (77 FR 64664) that, among other things, amended section 
560.530 of the Iranian Transactions and Sanctions Regulations, 31 CFR 
part 560 (ITSR), to add a general license, in new paragraph (a)(3), 
authorizing the exportation or reexportation of medicine and basic 
medical supplies to Iran. The term ``basic medical supplies'' was 
defined to mean those medical devices, as defined in paragraph (e)(3) 
of section 560.530, that were included on the ``List of Basic Medical 
Supplies'' on the OFAC Web site (www.treasury.gov/ofac) on the Iran 
Sanctions page, but not including replacement parts. On the same day, 
OFAC also posted the List of Basic Medical Supplies on its Web site (78 
FR 54731). OFAC updated the List of Basic Medical Supplies on its Web 
site on July 25, 2013, and subsequently published notice of the update 
in the Federal Register (78 FR 54731).
    On April 7, 2014, OFAC published a final rule in the Federal 
Register (79 FR 18990) that, among other things, updated the definition 
of ``basic medical supplies'' to exclude the word ``basic'' and make 
related conforming changes. Accordingly, the rule further provided that 
the ``List of Basic Medical Supplies'' published on the OFAC Web site 
and in the Federal Register would now be called the ``List of Medical 
Supplies.''
    As highlighted in the note to paragraph (a)(3)(ii) of section 
560.530 of the ITSR, the List of Medical Supplies is maintained on 
OFAC's Web site and will be published in the Federal Register, as will 
any changes to the list. On November 2, 2015, OFAC updated the List of 
Medical Supplies on its Web site to read as follows:

GENERAL LICENSE 31 CFR 560.530(a)(3), Authorizing the Exportation or 
Reexportation of Medicine and Medical Supplies to Iran

List of Medical Supplies (Updated November 2, 2015)

    The list below comprises the medical supplies defined in 31 CFR 
560.530(a)(3)(ii).

General Medical Equipment and Supplies

 Adhesive designed for human use
 Adhesive remover designed for human use
 Antiseptic wipes for human use (including alcohol, 
antimicrobial, benzalkonium, betadine, iodine, and witch hazel)
 Beds: Hospital beds, cribs, or bassinets; including 
mattresses, overlays, pillows, and bumpers
 Blood lancets
 Blood pressure monitors, gauges, cuffs, aneroids, or infusors
 Bottles (prescription)
 Cabinets: Medical supply or pharmaceutical
 Canes, crutches, walkers, rollators
 Capnographs
 Carts: medical, medical utility, medical supply, food service, 
or hospital laundry carts
 Catheters--all sizes and types; including kits
 Chairs: exam, treatment, surgical, dental, or phlebotomy
 Clinical basins, bowls, baths, pans, urinals, bags, and 
buckets; and holding devices for such items
 Clinical swabs, applicators, specimen collectors, sponges, 
pads, tongue depressors, wooden spoons, cotton balls, or cotton rolls
 Coils, guidewire
 Contraceptives (inter-uterine devices (IUDs), hormonal therapy 
methods, barrier methods), and condoms
 Continuous positive airway pressure (CPAP) systems and all 
components
 Ear plugs and muffs
 Ear syringes
 Ear wax removers
 Endoscopic devices including laryngoscopes, laparoscopes, 
anascopes, proctoscopes, arthroscopes, sinuscopes, dematoscopes, 
ophthalmoscopes, sigmoidscopes, otoscopes, retinoscopes, or colposcopes
 Floor mats: Safety, anti-fatigue or special-purpose medical 
floor mats
 Forceps
 Guidewires, all
 Human body or cadaver bags and shrouds
 Human body positioners including pads, wedges, cradles, 
pillows, rests, straps, supports, and holders
 Human specimen collectors and containers (e.g., urine, blood, 
tissue)
 Humidifiers
 Hydrocollator heating units
 IV sets, bags, and armboards
 Jars and containers designed for medical supplies and 
instruments less than 5 L internal volume
 Lights and lamps: Surgical, or medical exam, magnifying
 Limb prosthesis devices
 Manikins: Medical training, CPR
 Medical bags for medical supplies and equipment; including 
pre-packed bags
 Medical bandages, gauze, dressings, tape, swabs, sponges, and 
burn dressings

[[Page 75165]]

 Medical carafes, cups, containers and tumblers
 Medical casts, padding; and casting and removal equipment
 Medical defibrillators
 Medical diagnostic kits, point-of-care; including EAR99 
reagents
 Medical flowmeters: Oxygen & air
 Medical labels, labellers, stickers, forms, charts, signage, 
tags, cards, tape, wrist bands, documents, brochures, and graphics
 Medical lavage systems
 Medical linens (e.g., blankets, sheets, pillow cases, towels, 
washcloths, drapes, covers)
 Medical penlights
 Medical pumps
 Medical scissors
 Medical tubing or hoses less than 2'' diameter; including 
associated adaptors, connectors, caps, clamps, retainers, brackets, 
valves, washers, vents, stopcocks, or flow sensors; and peristaltic 
pumps with flowrates of less than 600 liters/hr for such tubing (Note: 
Does not include tubing made of butyl rubber or greater than 35% 
fluoropolymers)
 Medicine cups
 Monitor for glucose management
 Non-electronic patient medical record file systems and 
organizers
 Orthopedic supports, braces, wraps, shoes, boots, or pads
 Orthopedic traction devices and tables
 Otology sponges
 Oxygen apparatus, all
 Paraffin baths
 Patient heating and cooling devices: Pads, packs, bottles, 
bags, warmers, blankets, patches, lamps, bags
 Patient safety devices including vests, aprons, finger mitts, 
limb or body holders, jackets, belts, restraints, cuffs, straps, or 
protectors
 Patient transfer chairs, lifts, benches, boards, slides, 
discs, slings, and sheets
 Patient vital-sign monitoring devices
 Patient wheelchairs, chairs, gurneys, stretchers, mats, and 
cots
 Privacy screens and curtains
 Pulse oximeters
 Reflex hammers
 Refrigerator: Compartmental for morgues
 Safety poles, rails, handles, benches, grab bars, commode 
aids, and shower aids
 Scales, stadiometers, rulers, sticks, tapes, protractors, 
volumeters, gauges, or callipers designed for human measurement
 Single-use medical procedure trays and kits
 Speculums
 Spirometers
 Splints
 Stands: IV, instrument, solution, or hamper
 Stethoscopes
 Stools: Designed for clinical use
 Surgical sutures and staples; and removal kits
 Syringes, aspirators, cannulas, and needles--all sizes and 
types; including kits
 Tables: Operating, exam, therapy, overbed, treatment, medical 
utility, or medical instrument
 Telemetry pouches designed for human use
 Tents: Pediatric, aerosol, and mist
 Thermometers for measuring human body temperature
 Tourniquets
 Ventilator: Adult and tubing and accessories
 Warmers: Bottle, gel, lotion, or blanket

Anaesthesiology

 Air bags and tidal volume bags
 Air bellows
 Anaesthesia circuits
 Anaesthesia machines, vaporizers, nebulizers, and inhalers 
designed for individual human use
 Anaesthesia masks (including laryngeal)
 Anti-siphon equipment
 Block and epidural trays packaged for individual use
 Endotrach tubes
 Head straps and harnesses
 Hyperinflation systems
 In-line filters and cartridges, thermometers, CO2 
detectors, sodalime canisters, and temperature and moisture exchangers 
(Note: Gas mask canisters, other than sodalime canisters designed for 
anaesthesia systems, require a specific license)
 Intubation sets, probes and related equipment
 Anaesthesiometers
 Oral airways
 Peripheral nerve stimulators
 Anaesthesia pressure tubes and controllers
 Cardiopulmonary resuscitation (CPR) training manikins and lung 
bags
 Vibration dampening mounts

Apparel

 Medical gowns, scrubs, aprons, uniforms, lab coats, and 
coveralls; only those without integrated hoods
 Patient clothing including gowns, slippers, underpads, or 
undergarments
 Head or beard covers and nets
 Medical shoe and boot covers
 Surgical sleeve protectors
 Ventilated Safety eyeshields and goggles (does not include 
full face shield or indirectly-vented goggles)
 Disposable latex, nitrile, polyethylene, vinyl gloves/finger 
cots or other medical gloves
 Surgical face or dust masks (does not include masks with 
respirators)

Cardiology

 Ablation devices and accessories: Radio frequency
 Balloons extractor, retrieval
 Cardiac monitors: Implantable or external
 Cardiac pacemakers
 Cardiac programmers
 Cardiopulmonary oxygenation systems, devices, and monitors
 Coagulation machines
 Electrocardiography machines
 Filters: Arterial
 Grafts: Peripheral bypass
 Heart positioners: Surgical revascularization
 Heart valves: Surgical transcatheter (non-surgical)
 Inflation devices: Interventional

Dental Equipment and Supplies

 Bone graft matrices
 Dental and oral implants or devices
 Dental instrument cases, trays, mats or tray liners, racks, 
covers, wraps, stands, holders, stringers, or protectors
 Dental instruments--all types and sizes
 Denture and temporary oral device containers
 Dentures, crowns, molds, orthodontics, all
 Tooth and denture brushes
 Yankauers

Gynecology & Urology

 Bladder control pads, briefs, liners, underwear, pants and 
diapers
 Bladder scanners
 Enema sets
 Extracorporeal lithotripters
 Fecal/stool management devices, kits, and catheters
 Feminine hygiene products
 Pouches, urostomy

Inherited Preventative Care

 Genetic testing products

Laboratory

 Autoclaves (20 liters or smaller only) for medical instrument 
sterilization and accessories
 Automated blood culture systems
 Automated clinical chemistry analyzers for patient care
 Bench-top dry bath incubators
 Clinical immunoassay analyzers
 Clinical laboratory water baths less than 10 liter
 Coagulation analyzers
 Co-oximeters for haemoglobin analysis

[[Page 75166]]

 Electrolyte analyzers
 Flow cytometry accessories, reagents, and components
 Hematology analyzers
 Histology and cytology strainers and tissue baths
 Laboratory balances and scales not to exceed 10 Kg
 Laboratory hot plates with less than 1.0 sq. ft. heating 
surface
 Laboratory pH meter (with or without temperature probe)
 Light microscopes
 Luminometers
 Medical bone densitometers
 Medical differential counters
 Medical refrigerators and freezers with less than 5.0 cu. ft. 
internal volume
 Medical specimen centrifuges
 Microplate readers/washers
 Osmometers
 Patient blood gas analyzers
 Pipettes
 Spectrophotometers, photometers, and colorimeters designed for 
clinical use
 Urinalysis analyzers

Nephrology

 Hemodialysis machines; and dialysis filters designed for such 
machines (Note: Other dialysis equipment, filters, and parts not used 
for hemodialysis require a specific license and may be controlled under 
15 CFR, part. 774, supp. 1, ECCN 2B352.d)
 Hemodialysis connection or tubing kits

Neurology

 Electroencephalography machines
 Neurostimulators, implantable

Obstetrics and Maternity Care

 Assisted reproductive technology and related equipment
 Incubators/Isolettes
 Infant radiant warmer and parts and accessories
 Neonatal equipment (phototherapy, nasal CPAP, etc. and all 
components)
 Umbilical cord clamps
 Ventilator: Infant/pediatric and tubing and accessories

Ophthalmology and Optometry

 Contact Lens cleaning solutions
 Contact Lenses, corrective
 Eyecharts
 Glasses, corrective
 Phoropters
 Tonomets
 Vision/Optometry related machines and supplies

Otology and Neurotology

 Hearing aids, accessories, and components

Physical and Occupational Therapy

 Aquatic floats and training devices
 Balance pads, platforms, and beams
 Bath cubes, therapy
 Boots, mitts, and liners for therapeutic pain relief
 Cognitive measuring devices and equipment
 Dining aids
 Electrotherapy, muscle stimulators, and tens units
 Ergometers
 Exercise bars
 Exercise table
 Fine motor assessment equipment designed for human use
 Goniometers
 Hand bars
 Hydraulic dynamometer
 Manipulation boards
 Massaging equipment
 Mat Platforms
 Medical Whirlpools
 Mobility platforms, parallel bars, ladders, stairs
 Orthopedic shoes, boots, etc.
 Parallel bars
 Pedometers
 Protective headgear
 Rehabilitation exercise, weights, band, balls, boards, and 
mobility equipment
 Rulonmeters
 Scoliometer
 Tactile sensation, sensitization, and desensitization 
equipment
 Therapeutic putty
 Ultrasound stimulators

Radiology

 Computer tomography scanners (CT, MDCT)
 Contrasting agents, both injectable or non-injectable
 Magnetic resonance imaging (MRI) machines
 Medical ultrasound machines
 Medical/Dental film
 Nuclear medicine imaging machines
 Positron Emission Tomography (PET)
 PET cyclotron machines
 PET radiopharmaceutical tracer machines, including cassettes
 Scintillation Camera/Anger cameras for medical imaging
 Single Photon Emission Computed Tomography (SPECT) machines
 X-ray machines, including mammography machines
 Parts and accessories for medical imaging devices above that 
do not contain nuclear or chemical components

Sterilization

 Aseptic, germicidal, or disinfectant wipes or clothes for 
medical equipment, devices or furniture
 Ready-to-use disinfectant in 32 oz. containers or less
 Aseptic, germicidal, or medical-grade soap, detergent, pre-
soak, or rinse in 1 gallon containers or less
 Hand sanitizer, lotion, soap, scrub, wash, gel, or foam; 
including dispensing devices
 Medical cleaning brushes for equipment, patients, and 
furniture
 Sterilization or disinfection indicator strips, tape, or test 
packs
 Medical instrument sterilization pouches, mats, protector 
guards, or tubing
 Sterilization containers or cases less than 0.3 cu. ft.
 Autoclaves with chamber size less than 0.3 cu. ft.; including 
trays, containers, cassettes, cases, and filters for such systems.

Surgery

 Blood transfusion equipment
 Cervical fusion kits
 Chest drains
 Cosmetic or reconstructive implants (jaw implants, breast 
implants, skin grafts
 Electrosurgery devices and supporting equipment
 Lubricant specially-formulated for surgical equipment in 1 
gallon containers or less
 Orthopedic plates/screws, fixators, implants, cement
 Stents--all types and sizes
 Stockinettes
 Surgical case carts
 Surgical clean-up kits
 Surgical clips
 Surgical imaging machines; including image-guiding surgery 
products, ear, nose and throat
 Surgical instrument cases, trays, mats or tray liners, racks, 
covers, wraps, stands, holders, stringers, or protectors
 Surgical instruments--all types and sizes
 Surgical linens, drapes, or covers
 Surgical mesh
 Surgical shunts
 Surgical smoke evacuators and specialized supporting equipment
 Tissue stabilizers, surgical revascularizations
 Wound drainage equipment

    EAR99-classifed components, accessories, and optional equipment 
that are designed for and are for use with an EAR99-classified medical 
device included elsewhere on the list.
    With this notice, OFAC is publishing the updated list of items 
defined as medical supplies in the Federal Register.


[[Page 75167]]


    Issued: November 2, 2015.
John E. Smith,
Acting Director, Office of Foreign Assets Control.
[FR Doc. 2015-30207 Filed 11-30-15; 8:45 am]
BILLING CODE 4810-AL-P