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File: 970107_sep96_decls14_0009.txt
Page: 0009
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









          3. Hepatitis A Vaccine Inactivated
           1 a, IND # BB-IND-3200, sponsored by Smith-Kline-Beecham,
          Be gium. Merck sponsors IND # BB-IND-3252.

             h. Manufacturer: Smith-Kline-Beecham, and Merck.

             c. Indication: Prevent disease caused by hepatitis A virus.
          The indication cited in the IND is the indication intended for
          use in Operation Desert Shield.
             d. Operation Desert Shield Status: not required immediately.
             e. Consequences of not using hepatitis A iynmilnizations in
          operation Desert Shield: If a requirement is established, the
          consequences of non-use is the risk of endemic hepatitis A
          disease.

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

             g. Production Availability: pending.

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

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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