Areas Global TB Vaccine Foundation, Notice of Decision on Application for Duty-Free Entry of Scientific Instrument

This decision is made pursuant to Section 6(c) of the Educational, Scientific, and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, 80 Stat. 897; 15 CFR part 301). Related records can be viewed between 8:30 A.M. and 5:00 P.M. in Suite 4100W, U.S. Department of Commerce, Franklin Court Building, 1099 14th Street, NW, Washington, D.C.

Docket Number: 05-036. Applicant: Areas Global TB Vaccine Foundation. Instrument: Flow Cytometer. Manufacturer: Partec GmbH, Germany. Intended Use: See notice at 70 FR 48372, August 17, 2005.

Comments: None received. Decision: Approved. No instrument of equivalent scientific value to the foreign instrument, for such purposes as it is intended to be used, is being manufactured in the United States. Reasons: The foreign instrument provides: (1) true volumetric absolute cell counting, (2) validation of assay cell numbers that can be correlated to FDA approved cell counting devices, (3) stable lasers to permit use of the same settings regardless of the day or operator and (4) that the user can make corrections to the laser.

The National Institutes of Health advises: (1) these capabilities are pertinent to the applicant's intended purpose and (2) it knows of no domestic instrument or apparatus of equivalent scientific value to the foreign instrument for the applicant's intended use.

We know of no other instrument or apparatus of equivalent scientific value to the foreign instrument which is being manufactured in the United States.