MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0007.txt
Page: 0007
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











          BIOLOGIC PRODUCTS:

          1. Botulinum Toxoid Pentavalent

             a. IND # BB-IND-161, sponsored by the Centers for Disease
          Control.

             h. Manufacturer: Michigan Department Of Public Health.
             c. Indication: Active immunization against botulism. The
          indication cited in the IND is the indication intended for use in
          operation Desert Shield.
             d. Operation Desert Shield status: required immediately.
             e. Consequences of not using botulinum toxoid immunizations
          in Operation Desert Shield: For those at risk in the event of
          Biologic warfare involving botulism toxins, high mortality rates
          may occur. The use of botulinum toxoid is projected to minimize
          the risk of mortality, though for ethical reasons clinical
          efficacy studies have never been conducted in humans.
          significant immune responses have been achieved in humans in over
          lo,ooo vaccinations.

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

             g. Production Availability: 1 November 1990

             h. Point of contact: LTC Balady, 301-663-7661.

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