INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID

File: 120396_sep96_decls46_0003.txt
Page: 0003
Total Pages: 8

Subject: INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID             

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003204

Folder Title: INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID                                                   

Document Number:          1

Folder SEQ  #:         19




       09/07/90  15: 37 '&301 663 2982       IIQ USAMRDC   444 OTSG           F0003.,008

      SENT BY'@OG COIA. CENTER   a- 6-90  5:01   ATLANTA GEORelA U@@A-    3ol663i3o4;; A




                                            PREGAUTIQU


               1.   SOtUlinum tozoid is not a licensed        product and must be
               distributed as an Investigational Now Drug (IND) in accordance with
               requirements of the U, B. rood and Drug Administration (FDA),       it
               must be administered by or under the supervision of the physician
               who requested the tozold. The physician must be *scrolled as a ce-
               investigator by completing Form FD-1572, 'statement of
               Investigator'. The completed form should be returned to the CDC
               Drug Service (DO9)* Atlanta, Ga. 30333.

               2.   The toxoid should be administered only to healthy men and
               WOMbn, between the ages of I$ to 63 ysars, since investigations so
               far have been conducted exclusively tA that population.            The
               effects of adminietratiotl of the toxcid during pregnancy have not
               boon studied.    The tozoid should be given only to individuals
               working in high risk research laboratories that are actively
               working or expect to be working with known cultures and purified
               botuliniam toxins.   No one should. be administered a second or
               subsequent booster immunization unless laboratory testa have shown
               antitoxin type 8 and/or 'N to be below satisfactory level.

               3.   Each recipient must sign a consent f om, CDC 58. 43, one copy
               is given to the recipient; one copy is maintained by the clinical
               investigator; and the third copy is returned to the CDC Drug
               service.
               4.   Form CDC 519.7t "Response to Investigational New Drug", ulust
recipient and returned to the CDC Drug
                    Service.






















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Document 8 f:/Week-36/BX003204/INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID/informational brochure pentavalent botulinum tox:1122961634164
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003204
Unit = OTSG
Parent Organization = HSC
Folder Title = INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID
Folder Seq # = 19
Subject = INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOX
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 = 22-NOV-1996