Update to the List of Basic Medical Supplies

AGENCY:

Office of Foreign Assets Control.

ACTION:

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

SUMMARY:

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

DATES:

Effective Date: July 25, 2013.

FOR FURTHER INFORMATION CONTACT:

Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490, Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Policy, tel.: 202-622-2746, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202-622-2410, Office of the General Counsel, Department of the Treasury, Washington, DC 20220 (not toll-free numbers).

SUPPLEMENTARY INFORMATION:

Electronic and Facsimile Availability

This document 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) changing the heading of the Iranian Transactions Regulations, 31 CFR part 560, to the Iranian Transactions and Sanctions Regulations, 31 CFR part 560 (the “ITSR”), amending the renamed ITSR, and reissuing them in their entirety, to implement Executive Order 13599 of February 5, 2012 (“E.O. 13599”), and sections 1245(c) and (d)(1)(B) of the National Defense Authorization Act for Fiscal Year 2012 (Pub. L. 112-81). As part of those revisions, OFAC amended section 560.530 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 is defined in paragraph (a)(3)(ii) to mean those medical devices, as defined in paragraph (e)(3) of section 560.530, that are 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.

As highlighted in the note to paragraph (a)(3)(ii) of section 560.530 of the ITSR, the List of Basic 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 October 22, 2012, OFAC posted the following List of Basic Medical Supplies on its Web site:

Adhesive, surgical

Bandages (all)/Gauze/First aid dressings

Beds, hospital

Bed pans

Blood lancets

Blood collecting tubes

Burn dressings

Canes

Cannulae

Carts, all

Casts

Catheters, all

Chair, dental

Clips, surgical

Coils, guidewire

Contact Lenses, corrective

Cotton swabs

Crutches

Forceps

Glasses, corrective

Gloves, medical exam, surgical

Guidewires, all

Limb prosthesis

Medicine cup holder

Meter, portable (temperature/pH)

Monitor, glucose management

Needles, all

Padding, under cast

Pads, elbow & foot

Patient gowns, underpads, under garments

Pouches, urostomy

Scale, chair

Scalpels, disposable

Scrubs

Splints

Staples, surgical

Stents, all

Suture removal kits

Syringes

Thermometers, mercury for measuring human body temperature

Tongue depressors

Tube, drainage

Walkers

Wash basin, plastic

Wound drainage tubes

Wrist band, patient I.D.

On July 25, 2013, OFAC updated the List of Basic Medical Supplies on its Web site to read as follows:

General Medical Equipment and Supplies

• Syringes, cannulas, and needles—all sizes and types; including kits
• Catheters—all sizes and types; including kits
• Coils, guidewire
• Guidewires, all
• 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)
• Endoscopic devices including laryngoscopes, laparoscopes, anascopes, proctoscopes, arthroscopes, sinuscopes, dematoscopes, ophthalmoscopes, sigmoidscopes, otoscopes, retinoscopes, or colposcopes
• Blood pressure monitors, gauges, cuffs, aneroids, or infusors
• Monitor for glucose management
• Medical defibrillators
• Medical lavage systems
• IV sets, bags, and armboards
• Medical penlights
• Stethoscopes
• Speculums
• Medical scissors
• Forceps
• Single-use medical procedure trays and kits
• Medical diagnostic kits, point-of-care; including EAR99 reagents
• Reflex hammers
• Blood lancets
• Ear plugs and muffs
• Otology sponges
• Ear syringes
• Ear wax removers
• Clinical swabs, applicators, specimen collectors, sponges, pads, tongue depressors, wooden spoons, cotton balls, or cotton rolls
• Antiseptic wipes for human use (including alcohol, antimicrobial, benzalkonium, betadine, iodine, and witch hazel)
• Splints
• Canes, crutches, walkers, rollators
• Patient wheelchairs, chairs, gurneys, stretchers, mats, and cots
• Patient transfer chairs, lifts, benches, boards, slides, discs, slings, and sheets
• Safety poles, rails, handles, benches, grab bars, commode aids, and shower aids
• Patient vital-sign monitoring devices
• Limb prosthesis devices
• Orthopedic supports, braces, wraps, shoes, boots, or pads
• Medical casts, padding; and casting and removal equipment
• Orthopedic traction devices and tables
• Human body positioners including pads, wedges, cradles, pillows, rests, straps, supports, and holders
• Human specimen collectors and containers (e.g., urine, blood, tissue)
• Medical bandages, gauze, dressings, tape, swabs, sponges, and burn dressings
• Surgical sutures and staples; and removal kits
• Tourniquets
• Thermometers for measuring human body temperature
• Clinical basins, bowls, baths, pans, urinals, bags, and buckets; and holding devices for such items
• Medical carafes, cups, containers and tumblers
• Medicine cups
• Syringe aspirators
• Medical bags for medical supplies and equipment; including pre-packed bags
• Condoms
• Medical labels, labellers, stickers, forms, charts, signage, tags, cards, tape, wrist bands, documents, brochures, and graphics
• Non-electronic patient medical record file systems and organizers
• Beds: hospital beds, cribs, or bassinets; including mattresses, overlays, pillows, and bumpers
• Medical linens (e.g., blankets, sheets, pillow cases, towels, washcloths, drapes, covers)
• Chairs: exam, treatment, surgical, dental, or phlebotomy
• Stools: designed for clinical use
• Stands: IV, instrument, solution, or hamper
• Carts: medical, medical utility, medical supply, food service, or hospital laundry carts
• Tables: operating, exam, therapy, overbed, treatment, medical utility, or medical instrument
• Jars and containers designed for medical supplies and instruments less than 5 L internal volume
• Privacy screens and curtains
• Cabinets: medical supply or pharmaceutical
• Floor mats: safety, anti-fatigue or special-purpose medical floor mats
• Hydrocollator heating units
• Warmers: bottle, gel, lotion, or blanket
• Patient heating and cooling devices: pads, packs, bottles, bags, warmers, blankets, patches, lamps, bags
• Paraffin baths
• Lights and lamps: surgical, or medical exam, magnifying
• Scales, stadiometers, rulers, sticks, tapes, protractors, volumeters, gauges, or calipers designed for human measurement
• Patient safety devices including vests, aprons, finger mitts, limb or body holders, jackets, belts, restraints, cuffs, straps, or protectors
• Human body or cadaver bags and shrouds
• Adhesive designed for human use
• Adhesive remover designed for human use
• Telemetry pouches designed for human use

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

• Electrocardiography machines

Dental Equipment and Supplies

• Dental instruments—all types and sizes
• Dental instrument cases, trays, mats or tray liners, racks, covers, wraps, stands, holders, stringers, or protectors
• Dental and oral implants or devices
• Tooth and denture brushes
• Denture and temporary oral device containers
• Yankauers

Gynecology & Urology

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

Laboratory

• Laboratory balances and scales not to exceed 10 Kg
• Patient blood gas analyzers
• Medical specimen centrifuges
• Automated clinical chemistry analyzers for patient care
• Coagulation analyzers
• Co-oximeters for haemoglobin analysis
• Medical bone densitometers
• Medical differential counters
• Bench-top dry bath incubators
• Electrolyte analyzers
• Hematology analyzers
• Histology and cytology strainers and tissue baths
• Laboratory hot plates with less than 1.0 sq. ft. heating surface
• Clinical immunoassay analyzers
• Luminometers
• Laboratory pH meter (with or without temperature probe)
• Automated blood culture systems
• Microplate readers/washers
• Light microscopes
• Osmometers
• Pipettes
• Medical refrigerators and freezers with less than 5.0 cu. ft. internal volume
• Spectrophotometers, photometers, and colorimeters designed for clinical use
• Urinalysis analyzers
• Clinical laboratory water baths less than 10 liter

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

Obstetrics and Maternity Care

• Umbilical cord clamps

Ophthalmology and Optometry

• Contact Lenses, corrective
• Contact Lens cleaning solutions
• Glasses, corrective
• Eyecharts

Physical and Occupational Therapy

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

Radiology

• Medical ultrasound machines

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 sizes less than 0.3 cu. ft.; including trays, containers, cassettes, cases, and filters for such systems.

Surgery

• Surgical clips
• Surgical instruments—all types and sizes
• Surgical instrument cases, trays, mats or tray liners, racks, covers, wraps, stands, holders, stringers, or protectors
• Stents—all types and sizes
• Surgical linens, drapes, or covers
• Chest drains
• Surgical case carts
• Blood transfusion equipment
• Surgical clean-up kits
• Wound drainage equipment
• Stockinettes
• Surgical mesh
• Surgical smoke evacuators and specialized supporting equipment
• Electrosurgery devices and supporting equipment
• Lubricant specially-formulated for surgical equipment in 1 gallon containers or less

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 basic medical supplies in the Federal Register.