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Review of Sourcing Change, Foreign-Trade Subzone 7M, Amgen Manufacturing Limited (Biotechnology and Healthcare Products), Juncos, Puerto Rico

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Pursuant to the regulations of the Foreign-Trade Zones (FTZ) Board (the Board), a review has been initiated (under 15 CFR Sec. 400.28(a)(3)(iii)(A)) of changes in sourcing related to certain packaging products at Foreign-Trade Subzone 7M, at the facility of Amgen Manufacturing Limited (Amgen), in Juncos, Puerto Rico.

Subzone 7M was approved by the Board on December 11, 2008 (Board Order 1597, 73 FR 78290-78291, 12/22/08), for the manufacturing and distribution of biotechnology and healthcare products under FTZ procedures. On products shipped to the U.S. market, the company is able to choose the duty rate during customs entry procedures that applies to the finished products (duty-free) for the otherwise dutiable foreign components (duty-free to 2.7%). Components sourced from abroad include vials, syringes, stoppers, plunger rods, partitions and dispenser packs.

Amgen has now notified the Board of additional sourcing of foreign packaging components. The imported components are PVC film (duty rate 5.8%) and a plastic device to be used with a syringe in the self-injection process (duty rate, 5.3%). The use of FTZ procedures for the additional components could exempt Amgen from customs duty payments on the foreign components used in export production. The company estimates that some 48 percent of the plant's shipments are exported. On its domestic sales, Amgen would be able to choose the duty rate during customs entry procedures that applies to the finished pharmaceutical products (duty-free) for the foreign inputs noted above. The finished pharmaceutical products remain unchanged and were included in the scope of manufacturing authority approved by the FTZ Board.

In accordance with the Board's regulations, Elizabeth Whiteman is designated examiner to investigate the sourcing change, including its potential to cause “significant adverse effects”' (15 CFR 400.28(a)(3)(iii)(A)), and report to the Board.Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 13, 2009. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to April 27, 2009.

A copy of the sourcing change notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via​ftz.

For further information, contact Elizabeth Whiteman at or (202) 482-0473.

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Dated: March 5, 2009.

Andrew McGilvray,

Executive Secretary.

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[FR Doc. E9-5486 Filed 3-12-09; 8:45 am]