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NY G83402





October 27, 2000

CLA-2-49:RR:NC:2:234 G83402

CATEGORY: CLASSIFICATION

TARIFF NO.: 4901.99.0050; 9801.00.1010; Gen. Note 16-c, HTSUS

Ms. Diane L. Weinberg
Meeks & Sheppard, Attorneys at Law
330 Madison Avenue, 39th Floor
New York, N.Y. 10017

RE: The tariff classification of imported case record forms.

Dear Ms. Weinberg:

In your letter dated October 16, 2000, supplemented by that of October 20, 2000, both bearing your file control JJOMP-1, on behalf of your clients R.W. Johnson Pharmaceutical Research Institute and Janssen Pharmaceutical Research Foundation, subsidiaries of Johnson & Johnson, you requested a tariff classification ruling.

The goods in question are Case Record Forms that are designed for use in clinical trials of drugs, overseas. The forms are generally printed in the United States using both a lithographic printing process and high speed digital photocopying. However, the forms may also be printed overseas and imported into the United States. The forms are either placed in a looseleaf binder or collected and bound in a spiral notebook. (A sample was submitted with your letters, of a looseleaf binder containing numerous blank forms, and printed instructions for filling out the forms. This will be retained for reference, unless you require its return.)

The filled in forms capture information pertaining to the clinical trials conducted, and are used by the company to evaluate the drugs or compounds that are the subject of the clinical trials. The forms are not sold to third parties.

The ruling you request covers three scenarios, or sets of circumstances, concerning the importation of these articles: The binders or notebooks containing the clinical data are imported; the binders or notebooks, having been printed and manufactured in the United States, are returned without having had any data recorded on the forms thus bound; the binders or notebooks, having been printed and manufactured overseas, are imported without having had any data recorded in them.

In the case that the articles are returned containing the clinical trial data, for use by your clients in evaluating the drugs or compounds concerned, and not intended to be sold to third parties, they will be considered to be records and other data with regard to any business, as described in General Note 16-c, Harmonized Tariff Schedules of the United States (HTS). As such, they are not, for the purposes of General Note 1, goods subject to the provisions of the tariff schedule.

In the case that the Case Record Forms, as described, being the product of the United States, are imported without the clinical trial data having been recorded in them, the applicable subheading will be 9801.00.1010, HTS, which provides for: Products of the United States when returned after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad: Articles previously exported with intent to reimport after temporary use abroad. The rate of duty will be Free.

In the case that the Case Record Forms, as described, being the product a foreign country, are imported without the clinical trial data having been recorded in them, the applicable subheading will be 4901.99.0050, HTS, which provides for: Printed books, brochures, leaflets and similar printed matter, whether or not in single sheets: Other (than certain specified kinds): Technical, scientific and professional books. The rate of duty will be Free.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Carl Abramowitz at 212-637-7060.

Sincerely,

Robert B. Swierupski
Director,

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