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File: 970101_sep96_decls18_0005.txt
Subject: COVER SHEET FOR DOCUMENT TRANSMISSION
Unit: OTSG
Parent Organization: HSC
Box ID: BX003205
Folder Title: USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT
Document Number: 3
Folder Seq #: 13
Chemistryt
As soon as possible, the DOD should request that the
manufacturer submit to us the following manufacturing
datat
.1
(1) specifications and test procedures for the
active ingredients in this product#
(2) specifications anci specific test procedures for
TEA stearate and stearamide in the finished cream
formulation
(3) chemical assay data for the active ingredients,
TEA stuarate and stearamide MEA, at the various
stability test stations.
Other required, but less imperativwl manufacturing data
will be requested in a subsequent letter to you. The
manufacturer should be able to proviciw,you with that
information which can then be submitted to the IND.
Should questions arise concerning this INDG please contact Ms.
Rosemary Cook, Project Management Officer, at (301) 443-6797,
Sincerely yours,
Murray M. Lumpkin, M.D.
Director
Division of Anti-inlwctivip Drug Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research
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Document 5 f:/Week-36/BX003205/USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT/cover sheet for document transmission:12249609312319
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT
Folder Seq # = 13
Subject = COVER SHEET FOR DOCUMENT TRANSMISSION
Document Seq # = 3
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 = 24-DEC-1996