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File: 120396_sep96_decls73_0003.txt
Subject: BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY
Unit: OTSG
Parent Organization: HSC
Box ID: BX003203
Folder Title: BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY
Document Number: 1
Folder SEQ #: 66
Security and proximity to the U.S. Army Medical Research and
Development Command, the major medical biological defense base,
and availability of land makes Fort Detrick a possible location
for the proposed facility.
Production priorities will be established IAW threat and DOD
guidance. It is likely that the VPF will begin with vaccines
already being produced and then address vaccines in development
or vaccines no longer in commercial production. This strategy
has many advantages. First, it will give DOD the surge
capability and production flexibility it currently lacks.
Second, it allows DOD and FDA time to develop the required
procedures and Memorandum of Agreements, as necessary.
Successful production of existing vaccines will demonstrate
technical competence, the ability to conform with complex
regulatory requirements, and fulfills all generic requirements.
ACOUISITION STRATEGY. A initial design study has already been
started by the Corps of Engineers in coordination with the Health
Facilities Planning Agency. The study will be completed August
1993. This will provide the details necessary to begin the
formal design process. It will also define the personnel and
other requirements.
Funds have already been programmed by the Army. An
environmental assessment and economic analysis will, begin ,hortly
after the design start. The environmental assessment and 35
percent of the final design submission is to occur in PY94 so
that construction can take place in FY95. Construction is
projected to take two to three years. Pilot lot production and
FDA review will begin FY97. Vaccines will then be entered into
PY98/99.
SOURCE: )W KLENXE, DASG-HCD, (703) 756-8163
3
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Document 10 f:/Week-36/BX003203/BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY/biological defense vaccine production facility:11259610130813
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY
Folder Seq # = 66
Subject = BIOLOGICAL DEFENSE VACCINE PRODUCTION FACILITY
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 25-NOV-1996