Notice: Foreign-Trade Zone 7--Mayaguez, PR, Expansion of Manufacturing 
Authority; Amgen Manufacturing Limited (Biotechnology and Healthcare 
Products), Juncos, PR

Federal Register: Volume 76, Number 247 (Friday, December 23, 2011)
                  Pages 80332-80333
Agency:  DEPARTMENT OF COMMERCE
         Foreign-Trade Zones Board


    An application has been submitted to the Foreign-Trade Zones Board 
(the Board) by the Puerto Rico Industrial Development Company, grantee 
of FTZ 7, requesting an expansion of the scope of manufacturing 
authority approved within Subzone 7M, on behalf of Amgen Manufacturing 
Limited (Amgen) in Juncos, Puerto Rico. The application was submitted 
pursuant to the provisions of the Foreign-Trade Zones Act, as amended 
(19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 
400). It was formally filed on December 15, 2011.
    Subzone 7M (2,838 employees, 75 million vial and 38 million syringe 
capacity) was approved by the Board in 2008 for the manufacture of 
epogen[reg] (epoetin alfa), neupogen[reg] (filgrastim), aransep[reg] 
(darbepoetin alfa), enbrel[reg] (etanercept), kineret[reg] (anakinra), 
and neulasta[reg] (pegfilgrastim) (Board Order 1597, 73 FR 78290-78291, 
12-22-2008). The subzone facility (221 acres) is located at Road PR 31 
Km. 24.6, in Juncos, Puerto Rico.
    The current request involves an expansion of the capacity of the 
facility to 98 million vials and 50 million syringes as well as the 
addition of the following new products: Sensipar[reg] (cinacalcet), 
enbrel[reg] (enanercept) with auto injector and denosumab. New 
components and materials sourced from abroad (representing 1% of the 
value of the finished product) include: sucrose formulation, sodium 
citrate, sensipar bulk API, L-glutamine USP, antisera and blood 
fractions modified immunological products, resin, sunbright polyether, 
phenyl sepharose, acrylic polymers, auto injector devices, stoppers, 
plunger rods, partitions, dispenser packs, packing material, vials, 
filters and syringes (duty rate ranges from duty-free to 35.74[cent]/
kg). The application also requests authority to include a broad range 
of inputs and finished biotechnology and healthcare products that Amgen 
may produce under FTZ procedures in the future. New major activity 
involving these inputs/products would require review by the FTZ Board. 
The scope otherwise would remain unchanged.
    FTZ procedures could exempt Amgen from customs duty payments on the 
additional capacity and foreign components used in export production. 
The company anticipates that some 48 percent of the plant's shipments 
will be exported. On its domestic sales, Amgen would be able to choose 
the duty rates during customs entry procedures that apply to 
sensipar[reg] (cinacalcet), enbrel[reg] (enanercept) with auto injector 
and denosumab (duty-free) for the foreign inputs noted above. The 
request indicates that the savings from FTZ procedures help improve the 
plant's international competitiveness.
    In accordance with the Board's regulations, Elizabeth Whiteman of 
the FTZ Staff is designated examiner to evaluate and analyze the facts 
and information presented in the application and case record and to 
report findings and recommendations 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 
February 21, 2012. Rebuttal comments in response to material submitted 
during the foregoing period may be submitted during the subsequent 15-
day period to March 7, 2012.
    A copy of the application 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 Web site,

[[Page 80333]]

which is accessible via www.trade.gov/ftz.
    For further information, contact Elizabeth Whiteman at 
Elizabeth.Whiteman@trade.gov or (202) 482-0473.

    Dated: December 15, 2011.
Andrew McGilvray,
Executive Secretary.
[FR Doc. 2011-32937 Filed 12-22-11; 8:45 am]
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