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HQ 968245




September 7, 2006

CLA-2 RR:CTF:TCM 968245 HkP

CATEGORY: CLASSIFICATION

TARIFF NO.: 9019.20.0000

Don Zarin, Esq.
Holland & Knight, LLP
2099 Pennsylvania Avenue, NW
Suite 100
Washington, DC 20006

RE: Tariff classification of multi-dose dry powder inhaler parts; ADVAIR DISKUS

Dear Mr. Zarin:

This is in response to your letter of May 25, 2006, in which you requested a binding ruling on behalf of your client, SmithKlineBeecham Corporation d/b/a GlaxoSmithKline (“GSK”), regarding the tariff classification under the Harmonized Tariff Schedule of the United States (“HTSUS”) of certain medical grade component parts for a multi-dose dry powder inhaler device.

FACTS:

The ADVAIR DISKUS multi-dose dry powder inhaler (“ADVAIR DISKUS”) device is circular shaped, and measures approximately 8.5 cm in diameter and 3 cm in height. The items under consideration are the component parts of the ADVAIR DISKUS. There are 14 such parts, each injection molded and made of medical grade plastic. The parts will be imported as four separate items, described as:

(1) Sub-assembly unit, comprised of: (i) body base, (ii) dose wheel indicator, (iii) lever, (iv) base wheel, (v) idler gear, (vi) index ratchet, (vii) index wheel, (viii) contracting wheel column, (ix) contracting wheel ratchet gear, (x) contracting wheel, and (xi) manifold.

(2) Body top

(3) Mouthpiece

(4) Outer case

Samples of these items have been provided for our review. You have told us that the parts will be imported together as one entry and that these parts are the only ones necessary to make the ADVAIR DISKUS .

After importation the parts will be assembled into the ADVAIR DISKUS device, loaded with ADVAIR powder blister pack medicament and packaged. You have informed us that ADVAIR was approved by the Food and Drug Administration (“FDA”) in August 2000, for the treatment of asthma, and in November 2003, for the treatment of Chronic Obstructive Pulmonary Disease (“COPD”) associated with chronic bronchitis. You have also stated that the ADVAIR DISKUS is used solely with and for the delivery of the ADVAIR powdered medicament.

The ADVAIR DISKUS is specifically designed to disperse powdered medicament contained in a blister pack into the user’s lungs for the treatment of asthma and COPD. It is similar to a metered dose inhaler, but the drug is in powder form and is dispersed into the user’s airstream when upon inhalation through the mouthpiece. According to the product literature, a user must hold the ADVAIR DISKUS in a horizontal position in front of his mouth and slide the lever away from him as far as it will go until it clicks. This opens the blister pack. The user then puts the mouthpiece to his mouth, breathes in quickly and briefly through the ADVAIR DISKUS. The user then removes the ADVAIR DISKUS from his mouth, holds his breath for about ten seconds and then breathes out slowly. The user must then close the ADVAIR DISKUS device by sliding the lever (thumbgrip) toward himself as far as it will go. The device will click shut. Every time the lever is pulled back toward the user, a measured dose is ready to be inhaled. Like a metered dose inhaler, the ADVAIR DISKUS delivers a specific amount of medicine. It also has a built-in dose counter to keep track of the number of doses administered.

ISSUE:

What is the proper classification of the ADVAIR DISKUS?

LAW AND ANALYSIS:

Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.

Additional U.S. Rule of Interpretation 1(a) states that, in the absence of special language or context which otherwise requires, a tariff classification controlled by use (other than by actual use) is to be determined is accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use.

The HTSUS provisions under consideration are as follows:

3926 Other articles of plastics and articles of other materials of headings 3901 to 3914: 3926.90 Other:
3926.90.98 Other ..
3926.90.9880 Other ..

9019 Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof: 9019.20.0000 Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof ..

Note 2(r) to Chapter 39, HSTUS, provides that articles of Chapter 90 are excluded from classification in Chapter 39.

The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the HTSUS. While not legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80. You contend that the ADVAIR DISKUS is provided for in heading 9019, HTSUS, because it is a device used solely for the application of a therapeutic medicinal agent in the treatment of pulmonary illnesses. You also state that the ADVAIR DISKUS performs exactly the same function as aerosol therapy apparatus described in the Explanatory Notes to heading 9019, HTSUS.

As an initial matter we address the fact that all the components of the ADVAIR DISKUS are imported together as one entry. GRI 2 provides in relevant part:

Any reference in a heading to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as entered, the incomplete or unfinished article has the essential character of the complete or finished article. It shall also include a reference to than article complete or finished (or falling to be classified as complete or finished by virtue of this rule), entered unassembled or disassembled.

We find, therefore, that the ADVAIR DISKUS is a complete article entered into the United States in an unassembled or disassembled condition, classifiable in accordance with GRI 2(a). Hereafter, any reference to the ADVAIR DISKUS refers to its unassembled component parts.

Heading 9019, HTSUS, provides for, among other things, “aerosol therapy” and “other therapeutic respiration apparatus.” EN 90.19(V) explains, in relevant part, “oxygen therapy, artificial respiration or other therapeutic respiration apparatus” of heading 9019, HTSUS, “are used in cases of drowning, electrocution, acute poisoning (e.g., carbon monoxide), for weak newly-born babies, post-operative shock, infantile paralysis (poliomyelitis), acute asthma, insufficient lung development, etc.” Part (VI) explains that aerosol therapy apparatus “is used for the application of a therapeutic agent in the treatment of pulmonary, cutaneous, oto-rhino-laryngologic, gynaecologic diseases, etc., by the dispersion (nebulisation) in the form of a mist of various medicinal solutions (hormones, vitamins, antibiotics, brincho-dialting preparations, essential oils, etc.).” Heading 9019, HTSUS, is best described as a use provision because the defining feature of its enumerated articles is implied by their use.

We note that although the uses of aerosol therapy apparatus and therapeutic respiration apparatus are explained by the ENs, these terms are not defined by the tariff or the ENs. Tariff terms that are not defined in the HTSUS or in the ENs are construed in accordance with their common and commercial meaning. Nippon Kogaku (USA) Inc. v. United States, 69 CCPA 89, 673 F.2d 380 (1982). Common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities and other reliable sources. C.J. Tower & Sons v. United States, 69 CCPA 128, 673 F.2d 1268 (1982). Merriam-Webster’s Collegiate Dictionary (10th ed.) defines “aerosol” as “1 : a suspension of fine solid or liquid particles in gas 2 : a substance dispensed from a pressurized container”. “Therapeutic” is defined as being “of or related to the treatment of disease or disorders by remedial agents or methods”. “Respiration” is defined as “a single complete act of breathing.” Id. We find “therapeutic respiration apparatus” to be apparatus that relates to the treatment of a breathing disorder, and “aerosol therapy apparatus” to be apparatus that dispenses a remedial agent as a suspension of solid or liquid particles in gas to assist in the treatment of a disorder.

Based on the definitions stated above, we find that although the ADVAIR DISKUS may perform the same function as that of the aerosol therapy apparatus described in the ENs, it is not an aerosol device because the powdered medicament is not dispersed in a gas. However, based on the explanation provided in EN 90.19(V), we find that the principal use of the class of goods to which the multi-dose powder inhaler belongs is therapeutic respiration and, in particular, for the treatment of asthma and COPD. Accordingly, we find that the ADVAIR DISKUS is classified in heading 9019, HTSUS. This decision is consistent with previous decisions in which CBP classified similar devices in heading 9019, HTSUS. See New York Ruling Letter (“NY”) L83262, dated Mar. 25, 2006, and NY I86816, dated Oct. 1, 2002.

Finally, applying note 2(r) to chapter 39, HTSUS, to the instant facts, we find that the ADVAIR DISKUS is excluded from classification in chapter 39 because it is provided for in chapter 90, HTSUS.

HOLDING:

By application of GRI 2(a) and Additional U.S. Rule of Interpretation 1(a), we find that the ADVAIR DISKUS, imported in an unassembled or disassembled state, is provided for in heading 9019, HTSUS, and is specifically provided for in subheading 9019.20.0000, which provides for, inter alia: “ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; : artificial respiration or other therapeutic respiration apparatus.”

Sincerely,

Gail A. Hamill, Chief
Tariff Classification and Marking Branch

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