FR Notice Details

Application Information
027
00R
05/19/2021
Andover
MA
Wyeth Pharmaceuticals, LLC
Completed
B-039-2021
True
Notification of Proposed Production Activity; Wyeth Pharmaceuticals, LLC (mRNA Bulk Drug Substance); Andover, Massachusetts

Federal Register, Volume 86 Issue 95 (Wednesday, May 19, 2021) 
[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Page 27067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10514]

 

 

-----------------------------------------------------------------------

 

DEPARTMENT OF COMMERCE

 

Foreign-Trade Zones Board

 

[B-39-2021]

 

 

Foreign-Trade Zone (FTZ) 27--Boston, Massachusetts; Notification
of Proposed Production Activity; Wyeth Pharmaceuticals, LLC (mRNA Bulk
Drug Substance); Andover, Massachusetts

 

    Wyeth Pharmaceuticals, LLC (Wyeth) submitted a notification of
proposed production activity to the FTZ Board for its facility in
Andover, Massachusetts. The notification conforming to the requirements
of the regulations of the FTZ Board (15 CFR 400.22) was received on May
13, 2021.
    The Wyeth facility is located within Subzone 27R. The facility is
used for the production of mRNA bulk drug substance. Pursuant to 15 CFR
400.14(b), FTZ activity would be limited to the specific foreign-status
materials and components and specific finished product described in the
submitted notification (as described below) and subsequently authorized
by the FTZ Board.
    Production under FTZ procedures could exempt Wyeth from customs
duty payments on the foreign-status materials/components used in export
production. On its domestic sales, for the foreign-status materials/
components noted below, Wyeth would be able to choose the duty rate
during customs entry procedures that applies to mRNA bulk drug
substance (duty rate--6.5%). Wyeth would be able to avoid duty on

foreign-status materials/components which become scrap/waste. Customs
duties also could possibly be deferred or reduced on foreign-status
production equipment.
    The materials and components sourced from abroad include: 2-
Hexyldecanoic Acid; 4-Amino-1-Butanol; 2,2,6,6-Tetramethylpiperidine-1-
Oxyl; ATP--adenosine 5'-triphosphate; CTP--cytidine 5'-triphosphate;
GTP--guanosine 5'-triphosphate; Proteinase K; T7 RNA Polymerase;
EAM1104L enzyme; and, Ribolock Rnase-Free (Animal Origin Free) (duty
rate ranges from duty-free to 6.5%). The request indicates that certain
materials/components are subject to duties under Section 301 of the
Trade Act of 1974 (Section 301), depending on the country of origin.
The applicable Section 301 decisions require subject merchandise to be
admitted to FTZs in privileged foreign status (19 CFR 146.41).
    Public comment is invited from interested parties. Submissions
shall be addressed to the Board's Executive Secretary and sent to:
ftz@trade.gov. The closing period for their receipt is June 28, 2021.

    A copy of the notification will be available for public inspection
in the ``Reading Room'' section of the Board's website, which is
accessible via www.trade.gov/ftz.
    For further information, contact Diane Finver at
Diane.Finver@trade.gov or (202) 482-1367.

 

    Dated: May 13, 2021.
Andrew McGilvray,
Executive Secretary.
[FR Doc. 2021-10514 Filed 5-18-21; 8:45 am]
BILLING CODE 3510-DS-P