MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0006.txt
Page: 0006
Total Pages: 11

Subject: MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT     

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: MEDICAL PRODUCTS UNDER FDA REGULATIONS                                                          

Document Number:     930001

Folder Seq  #:     930000











         6.    Multi Shield

             a. IND # 35,291. 21 CFR 312.36 was invoked for the emergent
         procurement and shipment of Multi Shield in advance of submission
         of an IND sponsored by the US Army Office of the Surgeon General.
         The IND was submitted on 3 October 1990.

             b. Manufacturer - Interpro Inc, Haverhill, MA.

             C. Indication: For Operation Desert Shield the intended
         military use is for topical skin protection against sulfur
         mustard exposure. The product is intended to be used in
         conjunction with military chemical protective wear.

             d. Operation Desert Shield Status: Multi shield is the only
         commercially available product being considered for expeditious
         fielding as a topical skin protectant against mustard exposure.
         General officers at a conference held on 24 September 1990
         decided to expeditiously pursue fielding Multi Shield as a
         topical skin protectant against sulfur mustard.

             e. Consequences of not using Multi Shield in Operation
         Desert Shield: Morbidity associated with sulfur mustard exposure
         is expected to be more severe.

             f. Informed consent status: Informed consent will not be
         feasible.

             g. Projected Production Availability: Contractual efforts
         are underway to procure immediately.

             h. Point of contact: Colonel Harrington, 301-663-2051.

Document 11 f:/Week-36/BX003201/MEDICAL PRODUCTS UNDER FDA REGULATIONS/medical prod under fda reg required consider for:01029715471415
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = MEDICAL PRODUCTS UNDER FDA REGULATIONS
Folder Seq # = 930000
Subject = MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR
Document Seq # = 930001
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 = 02-JAN-1997